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Relationship between the Patient Activation Measure (PAM) & Adherenceto Mandibular Advancement Device Treatment for Obstructive Sleep ApneaAnderson, William Cameron 23 September 2020 (has links)
No description available.
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Étude comparative à court terme d’orthèses d’avancée mandibulaire titrable vs. active dans le traitement du syndrome d’apnées obstructives du sommeil chez l’adulte.Roca, Olivier 06 1900 (has links)
Introduction : Le syndrome d’apnées obstructives du sommeil (SAOS) est un problème de santé publique fréquent. La gestion par pression positive continue (TPPC) est la référence, mais de nombreuses personnes le refusent ou ne s’y adaptent jamais. Ainsi, les orthèses d’avancée mandibulaire (OAM) titrables gagnent en popularité car elles apportent des solutions concrètes et bien souvent durables. L’approche myofonctionelle, soit d’offrir des activités linguales, est une piste complémentaire qui pourrait améliorer la gestion du SAOS. C’est dans ce but que nous avons observé la combinaison de ces deux éléments par la réalisation d’une OAM active (OAMA). En effet, le repositionnement actif de la mandibule en position avancée pourrait bien atténuer certains effets indésirables de l’OAM conventionnelle.
Objectifs : Comparer, dans un environnement de soins courants, l’efficacité de l’OAMA à une OAM conventionnelle titrable chez des patients adultes atteints d’un SAOS sévère qui refusent ou sont intolérants au TPPC. L’évaluation se fera notamment par le taux de réponse globale qui inclut l’évolution de l’index d’apnée-hypopnée (IAH) et l’observance.
Méthodologie : 18 participants complétèrent la totalité de l’étude, 8 dans le groupe OAM et 10 dans le groupe OAMA. Après avoir rempli des questionnaires, ils ont été invité à un examen dentaire, articulaire et à une première polysomnographie (PSG). Tous ont reçu le traitement par orthèse. Après minimum 3 mois de port, une nouvelle série de questionnaires a été remplie, un nouvel examen clinique a été réalisé ainsi qu’une seconde PSG.
Résultats : L’IAH (p<0,001), le temps passé avec une saturation pulsée en dioxygène supérieure à 90% (p=0,002), l’index de désaturation (p=0,004) et le nombre de micro-éveil (p=0,007) ont significativement diminué dans les 2 groupes, sans différence significative entre les groupes. L’ensemble des résultats des questionnaires ont mis en évidence une amélioration significative entre le début et la fin de l’étude pour les 2 groupes sans toutefois de différence significative entre les deux types d’orthèses pour les variables sur la somnolence, la fatigue et les fonctions usuelles ou la qualité du sommeil Toutefois il y a significativement plus de salivation rapportée avec l’OAMA, plus de temps en éveil lors du sommeil et une tendance vers un port moins long au cours de la nuit. Une qualité du sommeil qui se normalise moins qu’avec l’OAM conventionnelle à aussi été notée. De façon subjective de par les rapports patients, à court terme, moins de claquements aux articulations temporo-mandibulaires (ATM) (p=0,05) et moins de changements d’occlusion (p=0,05) ont été rapportés par le groupe OAMA par rapport au groupe OAM. Enfin le taux de réponse globale ne différait pas de façon significative entre les groupes (p=0,64).
Conclusion : L’OAMA est une option de traitement équipotente pour les index de sommeil lorsqu’on la compare à une OAM titrable conventionnelle. Bien que l’OAMA engendre moins de claquements au niveau des ATM et de modifications occlusales à court terme, il est essentiel, par une étude à plus grande taille, de confirmer si les tendances à moins bien dormir et à ne pas utiliser l’OAMA pour une durée semblable à l’OAM peut s’expliquer. / Introduction: Obstructive sleep apnea syndrome (OSAS) is a common public health issue. Management with continuous positive airway pressure (CPAP) is the gold standard, but many people are unable to cope with it or refuse it. So, titratable mandibular advancement devices (MADs) are gaining in popularity, because they provide real long-term solutions. The myofunctional approach, which involves lingual exercises, is an additional measure that could improve OSAS management. To this end, we have observed the association of these two elements by creating an active MAD (AMAD). Indeed, actively repositioning the mandible in the advanced position may well mitigate some of the adverse effects of conventional MADs.
Objectives: To compare the efficacy of AMADs in a routine care environment with conventional titratable MADs in adult patients with severe OSAS who do not want or do not tolerate CPAP therapy. The evaluation will focus on the overall response rate, which includes changes in apnea-hypopnea index (AHI) and compliance.
Methodology: 18 participants completed the entire study, 8 in the MAD group and 10 in the AMAD group. After completing a series of questionnaires, they were asked to undergo a dental and temporomandibular joint (TMJ) examination, and their first polysomnography (PSG). They all received the treatment. After the patients had used it for at least 3 months, another series of questionnaires was completed, and another clinical examination and a second PSG were carried out.
Results: AHI (p <0.001), time spent with SpO2>90 (p = 0.002), desaturation index (p = 0.004) and number of micro-arousals (p = 0.007) significantly decreased in both groups, with no significant difference between groups. The overall results of the questionnaires showed a significant improvement between the beginning and the end of the study for both groups with no significant difference between the groups for drowsiness, fatigue, normal activities and sleep quality variables. However, a much higher salivation rate was reported with the AMAD, as well as longer wake times during sleep periods and a tendency for the device to be worn for less time during the night. It was also observed that sleep quality does not normalize as much as with conventional MADs. Subjectively, patients in the AMAD group reported fewer TMJ clicks (p = 0.05) and fewer occlusion changes (p = 0.05) in the short term, compared to the MAD group. Finally, there were no significant differences between the groups in the overall response rate (p = 0.64).
Conclusion: AMAD is an equipotent treatment option, based on sleep indexes, when compared to conventional titratable MADs. While AMADs produce subjectively less TMJ clicking and occlusal changes in the short term, it is essential to conduct a large-scale study to confirm whether the tendencies to not sleep as well and to use AMADs for shorter periods than MADs can be explained.
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Efficacité d'un appareil d'avancement mandibulaire dans le traitement des céphalées matinalesFranco, Laurent January 2009 (has links)
Mémoire numérisé par la Division de la gestion de documents et des archives de l'Université de Montréal.
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Efeitos do tratamento da síndrome da apneia obstrutiva do sono com aparelho de avanço mandibular em pacientes idosos, desdentados, em uso de próteses dentárias removíveis / Effects on the treatment of Obstructive Sleep Apnea Syndrome with a Mandibular Advancement Device in edentulous elderly patients wearing removable dental prosthesisSilveira, Isabele Trigueiro de Araújo Creazzola 03 September 2012 (has links)
O avançar da idade é reconhecidamente um fator de risco para a Síndrome da Apneia Obstrutiva do Sono (SAOS). O motivo dessa constatação está associado à diminuição do tônus da musculatura orofaringeana e à redução da Dimensão Vertical de Oclusão (DVO), esta última atribuída às perdas dentárias. A abordagem odontológica, no tratamento da SAOS, refere-se ao uso de Aparelho de Avanço Mandibular (AAM), que impede a obstrução, parcial ou total, da passagem do ar pela via respiratória alta, durante o sono. Os pacientes desdentados, no entanto, têm sido negligenciados, nos estudos atualmente realizados. Pelo exposto, este trabalho objetivou avaliar os efeitos do tratamento em variáveis polissonográficas, ronco, sonolência, qualidade do sono e ainda os efeitos colaterais pelo uso do AAM titulável, em pacientes idosos e desdentados portadadores de SAOS. A metodologia envolveu inicialmente, cinquenta pacientes, dos quais dezesseis realizaram polissonografia de noite inteira, com gravação do ronco, por meio de um Roncômetro, visando investigação objetiva do sono. Analisaram-se subjetivamente frequência e intensidade do ronco, por questionários. A Escala Visual Analógica de Ronco (EVAR), aplicada ao parceiro de quarto, permitiu, igualmente, que fosse avaliada a intensidade desse sintoma. A sonolência diurna foi quantificada pela Escala de Sonolência de Epworth e a qualidade do sono, pelo Índice de Qualidade do Sono de Pittsburgh. Confecção individualizada dos AAMs respeitou os princípios biológicos relativos à DVO. Durante uma semana após a instalação, os pacientes utilizavam o AMM sem qualquer avanço mandibular, visando redução de quaisquer desconfortos. Subsequentemente, o protocolo estabelecia titulação gradual e progressiva (30%, 50% e 70%) do aparelho. Transposta a etapa de adaptação, após um período superior a quinze dias, as avaliações iniciais foram repetidas Os efeitos colaterais pelo uso do AAM e adesão ao tratamento foram investigados, a partir de questionários. Doze pacientes completaram o estudo (83,3% mulheres), sendo a media de idade 68 anos e índice de massa corporal médio de 28,3 kg/m2. Os resultados permitiram observar reduções significantes no índice de dessaturação de O2 (17,710,1 eventos/h, p=0,05) e índice de apneia (3,10,9 eventos/h, p=0,02). O uso do AAM evidenciou também diminuições na latência do sono REM, movimentos períodicos de perna, saturação mínima de O2, índice de apneia e hipopneia, na posição supina (p>0,05). O estudo objetivo do ronco apontou redução de 49,522,6 eventos/h (p=0,07). Além do mais, as avaliações subjetivas de frequência (p=0,024) e intensidade (p=0,007) do ronco, EVAR (p=0,003), qualidade do sono (p=0,008), efeitos colaterais e adesão ao AAM foram estatisticamente significantes. Foi possível concluir pela eficácia do tratamento sobre algumas variáveis polissonográficas estudadas, parâmetros subjetivos do ronco e qualidade do sono. Ademais, os sintomas relatados, pelo uso do AAM, reduziram-se ao longo do tempo, o que permitiu, com vantagem, que houvesse maior adesão ao tratamento por parte dos pacientes inseridos nesta pesquisa. / Aging process is well known as a risky factor to Obstructive Sleep Apnea Syndrome (OSAS). Concomitant with this process, the reduction of orofacial and pharyngeal musculature tone, as well as the decrease of Vertical Occlusion Dimension (VOD), the latter attributed to tooth loss, have been considered as probable causal agents involved in OSAS pathogenesis. The Dentistry approach for OSAS treatment is commonly related to the use of Mandibular Advancement Devices (MAD), which could prevent partial or complete upper airway obstruction during sleep. However, this treatment has been scarcely used in toothless patients. The aim of this study was to assess the effects of a titratable MAD in polysomnographic (PSG) variables, snoring, sleepiness, sleep quality and side effects, in edentulous elderly patients with OSAS. Sixteen out of fifty patients assessed have been selected and have undergone an overnight polysomnographic study. Snoring was recorded by using suitable equipment, so that an objective assessment of sleep patterns could be made. The frequency and intensity of snoring have also been subjectively assessed by means of questionnaires. The Snoring Visual Analogic Scale (SVAS), posed to a bed partner, was also assessed to evaluate snoring intensity. Excessive daytime sleepiness and the quality of sleep have also been investigated by Epworth Sleepiness Scale and Pittsburgh Sleep Quality Index, respectively. The patients went through the whole process for individually manufacturing of the MAD following the biological principles of the VDO. A week after using the MAD, at 0% of mandibular advancement, the patients were invited to return in order to undergo a new evaluation according to their adaptation to MAD. Subsequently, a titration protocol was gradually established at 30%, 50% and 70% for mandibular advancement. After a period of at least fifteen days, which should correspond to an adjustment of patients to their devices, the same initial assessment procedures were repeated. The MAD collateral effects as well as the treatment acceptance have been investigated through questionnaires. Twelve patients (83,3% females) completed the study, with an average age of 68 years, body mass index of 28,3 kg/m2. The results showed a significant reduction in O2 desaturation index (17,710,1 event/h, p=0,05) and also in AI (3,10,9 events/h, p=0,02). The use of the MAD also represented reductions in the latency to REM sleep, periodical leg movements, minimum O2 saturation, apnea and hypopnea index (AHI) in supine position (p>0,05). The objective assessment of snoring showed a reduction, with no statistical relevance of the Snoring Index (49,522,6 events per hour of recording, p=0,07). The subjective assessment of frequency (p=0,024) and intensity of snoring (p=0,007), EVAR (p=0,003), sleep quality (p=0,008) and the MAD collateral effects as well as the treatment acceptance were also statistically significant. We observed that the OSAS treatment with MAD was effective in some polysomnografic variables studied as well as in the subjective parameters of snoring and sleep quality in edentulous elderly patients. The reported symptoms due to MAD use decreased over the time.
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Efficacité d'un appareil d'avancement mandibulaire dans le traitement des céphalées matinalesFranco, Laurent January 2009 (has links)
Mémoire numérisé par la Division de la gestion de documents et des archives de l'Université de Montréal
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Efeitos do tratamento da síndrome da apneia obstrutiva do sono com aparelho de avanço mandibular em pacientes idosos, desdentados, em uso de próteses dentárias removíveis / Effects on the treatment of Obstructive Sleep Apnea Syndrome with a Mandibular Advancement Device in edentulous elderly patients wearing removable dental prosthesisIsabele Trigueiro de Araújo Creazzola Silveira 03 September 2012 (has links)
O avançar da idade é reconhecidamente um fator de risco para a Síndrome da Apneia Obstrutiva do Sono (SAOS). O motivo dessa constatação está associado à diminuição do tônus da musculatura orofaringeana e à redução da Dimensão Vertical de Oclusão (DVO), esta última atribuída às perdas dentárias. A abordagem odontológica, no tratamento da SAOS, refere-se ao uso de Aparelho de Avanço Mandibular (AAM), que impede a obstrução, parcial ou total, da passagem do ar pela via respiratória alta, durante o sono. Os pacientes desdentados, no entanto, têm sido negligenciados, nos estudos atualmente realizados. Pelo exposto, este trabalho objetivou avaliar os efeitos do tratamento em variáveis polissonográficas, ronco, sonolência, qualidade do sono e ainda os efeitos colaterais pelo uso do AAM titulável, em pacientes idosos e desdentados portadadores de SAOS. A metodologia envolveu inicialmente, cinquenta pacientes, dos quais dezesseis realizaram polissonografia de noite inteira, com gravação do ronco, por meio de um Roncômetro, visando investigação objetiva do sono. Analisaram-se subjetivamente frequência e intensidade do ronco, por questionários. A Escala Visual Analógica de Ronco (EVAR), aplicada ao parceiro de quarto, permitiu, igualmente, que fosse avaliada a intensidade desse sintoma. A sonolência diurna foi quantificada pela Escala de Sonolência de Epworth e a qualidade do sono, pelo Índice de Qualidade do Sono de Pittsburgh. Confecção individualizada dos AAMs respeitou os princípios biológicos relativos à DVO. Durante uma semana após a instalação, os pacientes utilizavam o AMM sem qualquer avanço mandibular, visando redução de quaisquer desconfortos. Subsequentemente, o protocolo estabelecia titulação gradual e progressiva (30%, 50% e 70%) do aparelho. Transposta a etapa de adaptação, após um período superior a quinze dias, as avaliações iniciais foram repetidas Os efeitos colaterais pelo uso do AAM e adesão ao tratamento foram investigados, a partir de questionários. Doze pacientes completaram o estudo (83,3% mulheres), sendo a media de idade 68 anos e índice de massa corporal médio de 28,3 kg/m2. Os resultados permitiram observar reduções significantes no índice de dessaturação de O2 (17,710,1 eventos/h, p=0,05) e índice de apneia (3,10,9 eventos/h, p=0,02). O uso do AAM evidenciou também diminuições na latência do sono REM, movimentos períodicos de perna, saturação mínima de O2, índice de apneia e hipopneia, na posição supina (p>0,05). O estudo objetivo do ronco apontou redução de 49,522,6 eventos/h (p=0,07). Além do mais, as avaliações subjetivas de frequência (p=0,024) e intensidade (p=0,007) do ronco, EVAR (p=0,003), qualidade do sono (p=0,008), efeitos colaterais e adesão ao AAM foram estatisticamente significantes. Foi possível concluir pela eficácia do tratamento sobre algumas variáveis polissonográficas estudadas, parâmetros subjetivos do ronco e qualidade do sono. Ademais, os sintomas relatados, pelo uso do AAM, reduziram-se ao longo do tempo, o que permitiu, com vantagem, que houvesse maior adesão ao tratamento por parte dos pacientes inseridos nesta pesquisa. / Aging process is well known as a risky factor to Obstructive Sleep Apnea Syndrome (OSAS). Concomitant with this process, the reduction of orofacial and pharyngeal musculature tone, as well as the decrease of Vertical Occlusion Dimension (VOD), the latter attributed to tooth loss, have been considered as probable causal agents involved in OSAS pathogenesis. The Dentistry approach for OSAS treatment is commonly related to the use of Mandibular Advancement Devices (MAD), which could prevent partial or complete upper airway obstruction during sleep. However, this treatment has been scarcely used in toothless patients. The aim of this study was to assess the effects of a titratable MAD in polysomnographic (PSG) variables, snoring, sleepiness, sleep quality and side effects, in edentulous elderly patients with OSAS. Sixteen out of fifty patients assessed have been selected and have undergone an overnight polysomnographic study. Snoring was recorded by using suitable equipment, so that an objective assessment of sleep patterns could be made. The frequency and intensity of snoring have also been subjectively assessed by means of questionnaires. The Snoring Visual Analogic Scale (SVAS), posed to a bed partner, was also assessed to evaluate snoring intensity. Excessive daytime sleepiness and the quality of sleep have also been investigated by Epworth Sleepiness Scale and Pittsburgh Sleep Quality Index, respectively. The patients went through the whole process for individually manufacturing of the MAD following the biological principles of the VDO. A week after using the MAD, at 0% of mandibular advancement, the patients were invited to return in order to undergo a new evaluation according to their adaptation to MAD. Subsequently, a titration protocol was gradually established at 30%, 50% and 70% for mandibular advancement. After a period of at least fifteen days, which should correspond to an adjustment of patients to their devices, the same initial assessment procedures were repeated. The MAD collateral effects as well as the treatment acceptance have been investigated through questionnaires. Twelve patients (83,3% females) completed the study, with an average age of 68 years, body mass index of 28,3 kg/m2. The results showed a significant reduction in O2 desaturation index (17,710,1 event/h, p=0,05) and also in AI (3,10,9 events/h, p=0,02). The use of the MAD also represented reductions in the latency to REM sleep, periodical leg movements, minimum O2 saturation, apnea and hypopnea index (AHI) in supine position (p>0,05). The objective assessment of snoring showed a reduction, with no statistical relevance of the Snoring Index (49,522,6 events per hour of recording, p=0,07). The subjective assessment of frequency (p=0,024) and intensity of snoring (p=0,007), EVAR (p=0,003), sleep quality (p=0,008) and the MAD collateral effects as well as the treatment acceptance were also statistically significant. We observed that the OSAS treatment with MAD was effective in some polysomnografic variables studied as well as in the subjective parameters of snoring and sleep quality in edentulous elderly patients. The reported symptoms due to MAD use decreased over the time.
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The effect of oral appliance therapy on glycemic control in Type II diabetic patients with obstructive sleep apnea : a pilot randomized controlled trialSantini, Emily 06 1900 (has links)
Introduction : Le syndrome de l’apnée obstructive du sommeil (SAOS) est un trouble très prévalent chez les patients atteints du diabète de type 2 (DT2) et la littérature préconise un lien étroit entre le SAOS et la dysfonction glycémique. Cependant, les essais randomisés actuels évaluant le traitement du SAOS et les effets métaboliques chez les patients diabétiques sont limités au traitement par pression positive continue (PPC) – parcontre, une limitation majeure de ces études est une faible compliance. L’orthèse d’avancée mandibulaire (OAM) est une option de traitement alternative pour le SAOS qui est généralement mieux tolérée et acceptée par les patients que la PPC. Objectifs : L’objectif principal de cette étude est d’évaluer si un traitement de 3 mois avec une OAM améliore le contrôle glycémique chez les patients atteints du SAOS et le DT2 comparé à celui avec un appareil placébo. Les objectifs secondaires sont : 1) d’évaluer la faisabilité d’une OAM comme traitement du SAOS chez une population diabétique, 2) comparer les effets secondaires subjectifs ressentis lors du port de l’OAM ou de l’appareil placébo, 3) comparer les changements subjectifs dans la qualité de vie et sommeil avec les deux appareils, 4) comparer la compliance subjective et objective dans les deux groupes. Méthodes : 17 patients ont participé à cette étude pilote contrôlée et randomisée comparant le traitement du SAOS à l'aide d’une OAM (Somnodent®, n=7) et d'un appareil placébo (appareil Essix® mandibulaire, n=10). Des échantillons de sang mesurant le contrôle glycémique par les taux d'hémoglobine glyquée ont été prélevés avant et après le traitement. Trois polysomnographies ont été réalisées (au départ, après une période de titration de 2 mois et après une période de traitement de 3 mois). Tous les patients ont répondu à un questionnaire sur les effets indésirables après la période de titration. Les questionnaires suivants ont été comparés avant (V1), pendant (V4) et après (V6) le traitement : échelle de somnolence d’Epworth (ESS), questionnaire sur les résultats fonctionnels du sommeil (FOSQ), indice de qualité du sommeil de Pittsburg (PSQI), et l'échelle hospitalière d'anxiété et de dépression (HADS). Les patients ont rapporté leur compliance subjective dans un journal quotidien, et la compliance objective a été mesurée par une micropuce. Résultats : Aucune différence significative n'a été observée pour l’hémoglobine glycquée après 3-mois de traitement entre les deux groupes (p =0.75). L’OAM a présenté une diminution significative du SAOS mesurée par l'indice d'apnée-hypopnée (p =0.02) et l'indice de désaturation en oxygène (p =0.02). Aucune différence significative n'a été constatée lors de la comparaison des questionnaires sur les effets secondaires entre les groupes, plus précisément pour l'inconfort au niveau des mâchoires (p =0.15) et des changements occlusaux (p =0.41). La fréquence des complications était faible dans les deux groupes et n'a montré aucune différence significative (p =1.00). La satisfaction globale des patients était élevée dans les deux groupes et ne montrait aucune différence significative (p =1.00). Les deux groupes ont présenté des améliorations significatives des scores FOSQ (p =0.004 entre V1-4 et p =0.026 entre V1-6), des diminutions significatives pour ESS (p =0.023 entre V1-4), des diminutions significatives des scores d'anxiété (p =0.003 entre V1-4 et p =0.041 entre V1-6), ainsi qu’une diminution significative des scores de dépression (p =0.025 entre V1-6). Les patients du groupe avec OAM ont sur-rapporté de façon significative leur compliance subjective par rapport à la compliance objective mesurée par les micropuces (p =0.02). Conclusion : L’OAM est un traitement faisable pour le traitement du SAOS chez les patients atteints du DT2 et a démontré des effets secondaires minimes et un taux de satisfaction élevé. Un « effet placébo » important a été observé avec l’appareil placébo, ce qui souligne l’importance des études randomisées et contrôlées dans le domaine du traitement du SAOS. Les micropuces utilisées pour mesurer la compliance objective offrent des données plus fiables que les rapports subjectifs des patients. D'autres essais randomisés et contrôlés à grande échelle sont nécessaires, et des analyses futures d’un système de mesure de glucose en continue pourrait être plus précis pour évaluer les effets de l’OAM sur le contrôle glycémique ; l’investigation de phénotypes métaboliques chez certains patients qui pourraient mieux répondre au traitement de leur SAOS serait aussi important. / Introduction: Obstructive sleep apnea (OSA) is a disorder that is highly prevalent among patients with type 2 diabetes mellitus (T2DM) and the literature supports a strong link between OSA and glucose dysregulation. However, current randomized trials assessing the effect of OSA treatment on metabolic outcomes have been limited to continuous positive airway pressure (CPAP) therapy, and one of the main limitations of these studies is poor compliance. A mandibular advancement device (MAD) is an alternative treatment option for OSA that is generally better tolerated and accepted by patients than CPAP. Objectives: The main objective of this study is to evaluate if 3 months of treatment with a MAD will improve glycemic control in patients with OSA and T2DM as compared to a Placebo Device. Secondary objectives will be: 1) to evaluate the feasibility of a MAD to treat sleep apnea in a diabetic population, 2) to compare subjective side effects of the MAD and Placebo Device, 3) to compare subjective changes in quality of life and sleep with both devices, and 4) to compare subjective and objective compliance in both groups. Methods: 17 patients participated in this randomized controlled pilot study, comparing treatment of OSA using a MAD (Somnodent, n=7) and a placebo device (mandibular Essix, n=10). Blood samples measuring glycemic control by glycated hemoglobin levels were collected before and after treatment. Three polysomnographies were performed (at baseline, after a 2-month titration period and after a 3-month treatment period). All patients answered a side-effects questionnaire after the titration period, and the following questionnaires were compared before (V1), during (V4) and after treatment (V6): Epworth Sleepiness Scale (ESS), the Functional Outcomes of Sleep Questionnaire (FOSQ), the Pittsburg Sleep Quality Index (PSQI), and the Hospital Anxiety and Depression Scale. Patients recorded subjective compliance in a daily journal, and objective compliance was measured by a microchip. Results: No significant difference was found in glycated hemoglobin levels between groups (p=0.75). The MAD group showed a significant decrease in OSA as measured by the Apnea-Hypopnea Index (p=0.02) and the Oxygen Desaturation Index (p=0.02). No significant difference was found when comparing Side Effects Questionnaires between groups, more specifically for discomfort in jaws (p=0.15) and changes in occlusion (p=0.41). Frequency of complications were low in both groups and showed no significant differences (p=1.00). Overall patient satisfaction was high in both groups and showed no significant differences (p=1.00). Both groups showed significant improvements in FOSQ scores (p=0.004 between V1-4, and p=0.026 between V1-6), significant decreases in ESS (p= 0.023 between V1-4), significant decreases in Anxiety scores (p=0.003 between V1-4, and p=0.041 between V1-6), as well as a significant decrease in Depression scores (p=0.025 between V1-6). Patients in the MAD group significantly over-reported their subjective compliance as compared to the objective compliance measured by a microchip (p=0.02). Conclusion: MAD is a feasible treatment for OSA in patients with T2DM as it was able to significantly improve OSA while demonstrating high overall satisfaction and minimal complications. A strong “placebo effect” was noted with the Placebo Device and reinforces the importance of randomized and controlled studies in the field of OSA treatment. Microchips to measure objective compliance should be used as they offer more reliable data than subjective records. Further large-scale randomized and controlled trials are required, as well as future analyses of Continuous Glucose Monitoring Systems which may allow for more precise evaluation of glycemic outcomes; investigating possible metabolic phenotypes in patients which may respond better to OSA treatment will be important.
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