Diabetes-Obstructive Sleep Apnea Treatment Trial

Not Applicable

Terminated

Conditions: Obstructive Sleep Apnea
Type 2 Diabetes

Registration Number: NCT01901055

Lead Sponsor: Eileen R. Chasens

Brief Summary: 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: 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

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 98

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1C Level	baseline, 6 weeks, 12 weeks	Glycated hemoglobin test that estimates the blood glucose level over last 2 to 3 months. Higher scores indicate worse diabetes control.

Secondary Outcome Measures

Name	Time	Method
Fructosamine Level	baseline, 6 weeks, 12 weeks	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.
Diabetes Diet Adherence	baseline, 6 weeks, 12 weeks	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
Diabetes Knowledge	baseline,12 weeks only	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)
Self-Monitoring of Blood Glucose (SMBG)	baseline, 6 weeks, 12 weeks	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
Steps Walked	baseline, 6 weeks, 12 weeks	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.
Self-Monitoring of Foot Care	baseline, 6 weeks, 12 weeks	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
Diabetes-Related Distress	baseline, 6 weeks, 12 weeks	Score of the Problem Areas in Diabetes (PAID) Questionnaire; scores range from 0-100, higher scores indicate worse diabetes-related distress.
Sleep Quality	baseline, 6 weeks, 12 weeks	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.
Mood	baseline, 6 weeks, 12 weeks	Mood impairment measured by the Profile of Mood States (POMS) total score; potential scores range from 0 to 60; higher scores indicate worse mood.
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	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.

Trial Locations

Locations (4): John D. Dingell VAMC
🇺🇸
Detroit, Michigan, United States
Pittsburgh Veterans Administration Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
University of Pittsburgh
🇺🇸
Pittsburgh, Pennsylvania, United States
West Virginia University
🇺🇸
Morgantown, West Virginia, United States
John D. Dingell VAMC
🇺🇸Detroit, Michigan, United States