Diabetes-Obstructive Sleep Apnea Treatment Trial (DOTT)

Eileen R. Chasens

Status: Terminated

Conditions: Type 2 Diabetes; Obstructive Sleep Apnea

Treatments: Device: Sham-CPAP; Device: CPAP; Behavioral: Diabetes Education

Study type: Interventional

Funder types: Other

Identifiers

NCT01901055

5R01DK096028-02

Details and patient eligibility

About

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.

Full 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

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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98 participants in 2 patient groups, including a placebo group

Active CPAP treatment

Experimental group

Description:

Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)

Treatment:

Behavioral: Diabetes Education

Device: CPAP

Sham-CPAP

Placebo Comparator group

Description:

Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.

Treatment:

Behavioral: Diabetes Education

Device: CPAP

Device: Sham-CPAP