Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy (HYPNOS)
3 mai 2021 mis à jour par: Johns Hopkins University
This is a randomized control trial in people with diabetes and obstructive sleep apnea who will be randomly assigned for 3 months to PAP therapy along with healthy lifestyle and sleep education or healthy lifestyle and sleep education.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Research over the last decade has shown that obstructive sleep apnea (OSA) is a common condition in people with diabetes.
Observational and experimental evidence also indicates that intermittent hypoxemia and recurrent arousals in OSA may alter glucose metabolism and worsen glycemic control.
However, the impact of treating OSA with positive airway pressure (PAP) therapy on glycemic variability and control is not well defined.
Adequately powered randomized clinical trials have yet to be performed to demonstrate whether PAP therapy for OSA in diabetics can improve glycemic variability (and control), decrease blood pressure, and reverse endothelial dysfunction.
The overarching goal of this study is to determine whether PAP therapy for OSA in diabetics leads to improvements in (a) glycemic variability as assessed by self-monitoring of blood glucose and continuous monitoring of glucose; (b) glycosylated hemoglobin; (c) blood pressure; (d) endothelial function; (e) serum and urinary biomarkers; and (f) dyslipidemia.
Type d'étude
Interventionnel
Inscription (Réel)
184
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Maryland
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Baltimore, Maryland, États-Unis, 21224
- Johns Hopkins Bayview Medical Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
21 ans à 75 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Type 2 diabetics
- Age > 21 and ≤ 75 years
Exclusion Criteria:
- Inability to consent or commit to the required visits
- Use of insulin or other injections for diabetes
- Weight change of 10% in last six months
- Use of oral steroids in the last six months
- Pulmonary disease (i.e., COPD)
- Renal or hepatic insufficiency
- Recent MI or stroke (< 3 months)
- Sleep-related hypoventilation
- Obesity-hypoventilation syndrome
- Morbid Obesity
- Occupation as a commercial driver or operator of heavy machinery
- Active substance use
- Untreated thyroid disease
- Pregnancy
- Any history of seizures or other neurologic disease
- Poor sleep hygiene or sleep disorder other than sleep apnea
- Central sleep apnea
- Variants of obstructive sleep apnea (e.g., REM-related OSA)
- Participants not suitable for the study based on the clinical judgment
- Use of any investigational drug within the past 30 days
- Participating in another study
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: REMStar Positive Airway Pressure
Positive pressure therapy is the standard of care for managing obstructive sleep apnea.
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Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea
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Autre: LifeStyle Counseling
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
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Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Continuous Glucose Monitoring System Standard Deviation
Délai: Baseline and 3 months
|
Continuous Glucose Monitoring Metrics - change in standard deviation between baseline and three months.
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Baseline and 3 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean Difference in Systolic Blood Pressure
Délai: Baseline and 3 months
|
Mean difference between 3 months and baseline systolic blood pressures (in mmHg) by group.
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Baseline and 3 months
|
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Change in Endothelial Dysfunction as Assessed by the Reactive Hyperemic Index
Délai: Baseline and 3 months
|
Endothelial function was measured by the EndoPAT device - difference at 3 months - baseline, by group.
The outcome reported is the Reactive Hyperemic Index (RHI).
The RHI is a measure of endothelial vasodilator function.
The RHI is the post-to-pre occlusion peripheral arterial tone signal ratio in the occluded arm relative to the other arm, which is not occluded.
Persons with worse endothelial function have a lower RHI score.
Consequently, a low RHI indicates more endothelial dysfunction.
A value of 1.67 or less is considered abnormal vascular tone.
The reported lower and upper limits in adults with type 2 diabetes is 1.1 - 4.9.
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Baseline and 3 months
|
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Heart Rate Variability
Délai: 3 months
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3 months
|
|
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Change in the Epworth Sleepiness Scale
Délai: Baseline and 3 months
|
The Epworth Sleepiness Scale measures self-reported sleep propensity or daytime sleepiness.
The range of the scale is 0 to 24 (integers only), with increasing values corresponding to increasing sleepiness.
A cut-point of ≥ 11 is also sometimes used to differentiate those with pathological sleepiness (≥ 11) versus those without < 11.
The difference between the three month final visit - the baseline visit score is reported by group
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Baseline and 3 months
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Change in Post-Pre Meal Blood Glucose Levels
Délai: Baseline and 3 months
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The difference from baseline to three months in self-reported in blood glucose levels before and after meals (mg/dL) (post-meal - pre-meal).
Data is presented for breakfast, lunch, and dinner.
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Baseline and 3 months
|
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Change in Glycosylated Hemoglobin A1c Level
Délai: Baseline and 3 months
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Change in point-of-care hemoglobin A1c (%) after three months.
|
Baseline and 3 months
|
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Continuous Glucose Monitoring System Mean Amplitude Glucose Excursion
Délai: 3 months
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Mean Amplitude Glucose Excursion in mg/dL (difference between the peaks and troughs of glucose from continuous glucose monitoring at three months).
|
3 months
|
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Continuous Glucose Monitoring System Standard Deviation
Délai: 3 months
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The standard deviation of the glucose from continuous glucose monitoring at three months.
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3 months
|
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Change in Continuous Glucose Monitoring System Mean Glucose
Délai: Baseline and 3 months
|
Continuous Glucose Monitoring Metric - change in average glucose level (mg/dL) from baseline to three months.
|
Baseline and 3 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Naresh M Punjabi, MD, PhD, Johns Hopkins University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 décembre 2014
Achèvement primaire (Réel)
15 mars 2020
Achèvement de l'étude (Réel)
15 mars 2020
Dates d'inscription aux études
Première soumission
14 janvier 2015
Première soumission répondant aux critères de contrôle qualité
26 mai 2015
Première publication (Estimation)
27 mai 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
25 mai 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 mai 2021
Dernière vérification
1 mai 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NA_00093188
- R01HL117167 (Subvention/contrat des NIH des États-Unis)
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