Diabetes-Obstructive Sleep Apnea Treatment Trial

Study Overview
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Brief Summary
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Diabetes self-management is important to help adults with type 2 diabetes achieve glucose control. Obstructive sleep apnea often co-exists with type 2 diabetes and may act as a barrier to diabetes self-management and glucose control. We will examine if treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP), combined with diabetes education, results in improved diabetes self-management and glucose control.

Detailed Description
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While diabetes self-management has been improved and refined over the last 30 years, many persons with T2DM continue to have difficulty in achieving glycemic goals. Obstructive sleep apnea (OSA) has a high prevalence among adults with type 2 diabetes (T2DM) and is associated with excessive daytime sleepiness, impaired mood, decreased vigilance, and reduced functional outcomes. The degree that OSA affects diabetes self-management, a known determinant of glycemic control, remains unstudied. The most effective treatment for OSA, continuous positive airway pressure (CPAP), results in improved self-reported daytime functioning. However, the effect of CPAP treatment on reception of diabetes education remains unknown. The underlying premise of the proposed study from this new investigator is that OSA hinders diabetes self-management in adults with T2DM. Our goal is to improve understanding of the effect of OSA on diabetes self-management and to determine the efficacy of CPAP treatment in improving diabetes outcomes in adults treated with CPAP compared to those on sham-CPAP. Expanding our understanding of the effect of sleep disturbances on diabetes self-management may lead to improved guidelines for screening and treatment of OSA in the increasingly large portion of the population with diabetes

Official Title
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The Effect of Treatment of Obstructive Sleep Apnea on Diabetes Self Management and Glycemic Control

Conditions
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Type 2 Diabetes, Obstructive Sleep Apnea

Intervention / Treatment
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* Device: CPAP
* Device: Sham-CPAP
* Behavioral: Diabetes Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suboptimal glucose control (A1C ≥ 6.5%) Moderate-to-severe obstructive sleep apnea (apnea + hypopnea index >= 10/hour) age 18 years and older Exclusion Criteria: Poor glucose control (A1C > 11) Type 1 or gestational diabetes Sleep duration < 4 hrs Acute medical or surgical conditions or hospitalization ≤ 3 months Oxygen or bi-level PAP required Prior CPAP or persons in household with CPAP Employed in safety sensitive job Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel was a one-way cross over after 12 weeks with persons originally in the sham group being titrated onto active CPAP.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active CPAP treatment<br>Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) | Device: CPAP<br>* CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).<br>* Other names: Continuous Positive Airway Pressure;Behavioral: Diabetes Education<br>* Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)<br>|
| Placebo Comparator: Sham-CPAP<br>Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment. | Device: CPAP<br>* CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).<br>* Other names: Continuous Positive Airway Pressure;Device: Sham-CPAP<br>* Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).<br>* Other names: Sham Continuous Positive Airway Pressure;Behavioral: Diabetes Education<br>* Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1C Level | Glycated hemoglobin test that estimates the blood glucose level over last 2 to 3 months. Higher scores indicate worse diabetes control. | baseline, 6 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fructosamine Level | Measurement of glucose in plasma that estimates the blood glucose level over last 10 days to 3 weeks. The normal range is from 221.00 to 451.00. | baseline, 6 weeks, 12 weeks | 
| Diabetes Diet Adherence | Diabetes Diet Adherence score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that was adherent to diabetes diet, range from minimum=0 days to maximum=7 days; higher number indicates better adherence to diabetes diet | baseline, 6 weeks, 12 weeks | 
| Diabetes Knowledge | Score on the Diabetes Knowledge Test. Scores range minimum=0 to maximum=100, higher scores indicate higher knowledge (this measure only done at 12 weeks) | baseline,12 weeks only | 
| Self-Monitoring of Blood Glucose (SMBG) | SMBG score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that SMBG was done, range from 0 days to 7 days; higher number indicates better SMBG | baseline, 6 weeks, 12 weeks | 
| Steps Walked | Average number of steps walked daily; measured by BodyMedia Armband; higher numbers indicate more steps walked. The range is from 397.83 to 16839.00. | baseline, 6 weeks, 12 weeks | 
| Self-Monitoring of Foot Care | Foot Care score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that foot care was done, range from 0 days to 7 days; higher number indicates better adherence to foot care | baseline, 6 weeks, 12 weeks | 
| Diabetes-Related Distress | Score of the Problem Areas in Diabetes (PAID) Questionnaire; scores range from 0-100, higher scores indicate worse diabetes-related distress. | baseline, 6 weeks, 12 weeks | 
| Sleep Quality | Sleep Quality is measured by the Pittsburgh Sleep Quality Index (PSQI) - Higher scores indicate worse sleep quality. The potential range is from 0 to 27 with higher scores indicating worse sleep quality. | baseline, 6 weeks, 12 weeks | 
| Mood | Mood impairment measured by the Profile of Mood States (POMS) total score; potential scores range from 0 to 60; higher scores indicate worse mood. | baseline, 6 weeks, 12 weeks | 
| Vigilance | Ability to maintain attention (i.e. vigilance); Measured by the Psychomotor Vigilance Test primary metric being transformed lapses (i.e. when person does not respond to a visual stimuli in a reaction time test). Normal values are <=2 lapses within the 10 minute test. Higher scores indicate worse vigilance. | Administered during diabetes education sessions done within the first 6 weeks of study; baseline, approximately 3 weeks after starting CPAP, and at the 2nd diabetes education session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep apnea, diabetes