Clinical trial NCT01901055: Diabetes-Obstructive Sleep Apnea Treatment Trial
Official title: The Effect of Treatment of Obstructive Sleep Apnea on Diabetes Self Management and Glycemic Control
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 2 Diabetes
Obstructive Sleep Apnea
Keywords: sleep apnea
diabetes
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2013-07-17
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel was a one-way cross over after 12 weeks with persons originally in the sham group being titrated onto active CPAP.
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: HbA1C Level
timeFrame: baseline, 6 weeks, 12 weeks
Secondary outcomes:
measure: Fructosamine Level
timeFrame: baseline, 6 weeks, 12 weeks
measure: Diabetes Diet Adherence
timeFrame: baseline, 6 weeks, 12 weeks
measure: Diabetes Knowledge
timeFrame: baseline,12 weeks only
measure: Self-Monitoring of Blood Glucose (SMBG)
timeFrame: baseline, 6 weeks, 12 weeks
measure: Steps Walked
timeFrame: baseline, 6 weeks, 12 weeks
measure: Self-Monitoring of Foot Care
timeFrame: baseline, 6 weeks, 12 weeks
measure: Diabetes-Related Distress
timeFrame: baseline, 6 weeks, 12 weeks
measure: Sleep Quality
timeFrame: baseline, 6 weeks, 12 weeks
measure: Mood
timeFrame: baseline, 6 weeks, 12 weeks
measure: Vigilance
timeFrame: 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
Other outcomes:
Locations:
city: Detroit
country: United States
facility: John D. Dingell VAMC
state: Michigan
city: Pittsburgh
country: United States
facility: Pittsburgh Veterans Administration Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: University of Pittsburgh
name: Eileen R. Chasens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Imes CC, Bizhanova Z, Sereika SM, Korytkowski MT, Atwood CW Jr, Burke LE, Kariuki J, Morris JL, Stansbury R, Strollo PJ Jr, Chasens ER. Metabolic outcomes in adults with type 2 diabetes and sleep disorders. Sleep Breath. 2022 Mar;26(1):339-346. doi: 10.1007/s11325-021-02408-x. Epub 2021 Jun 9.
citation: Chasens ER, Atwood CW, Burke LE, Korytkowski M, Stansbury R, Strollo PJ, Sereika SM. Diabetes sleep treatment trial: Premise, design, and methodology. Contemp Clin Trials. 2019 Jan;76:104-111. doi: 10.1016/j.cct.2018.11.014. Epub 2018 Dec 2.