The Effect of Treatment of Obstructive Sleep Apnea on Diabetes Self Management and Glycemic Control
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 98
- 试验地点
- 4
- 主要终点
- HbA1C Level
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suboptimal glucose control (A1C ≥ 6.5%)
- •Moderate-to-severe obstructive sleep apnea (apnea + hypopnea index >= 10/hour)
- •age 18 years and older
排除标准
- •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
研究组 & 干预措施
Active CPAP treatment
Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)
干预措施: CPAP (Device)
Active CPAP treatment
Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)
干预措施: Diabetes Education (Behavioral)
Sham-CPAP
Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.
干预措施: CPAP (Device)
Sham-CPAP
Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.
干预措施: Sham-CPAP (Device)
Sham-CPAP
Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.
干预措施: Diabetes Education (Behavioral)
结局指标
主要结局
HbA1C Level
时间窗: 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.
次要结局
- Diabetes Knowledge(baseline,12 weeks only)
- Fructosamine Level(baseline, 6 weeks, 12 weeks)
- Diabetes Diet Adherence(baseline, 6 weeks, 12 weeks)
- Self-Monitoring of Blood Glucose (SMBG)(baseline, 6 weeks, 12 weeks)
- Steps Walked(baseline, 6 weeks, 12 weeks)
- Self-Monitoring of Foot Care(baseline, 6 weeks, 12 weeks)
- Diabetes-Related Distress(baseline, 6 weeks, 12 weeks)
- Sleep Quality(baseline, 6 weeks, 12 weeks)
- Mood(baseline, 6 weeks, 12 weeks)
- 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)
研究者
Eileen R. Chasens
Professor of Nursing
University of Pittsburgh