Influence of Exercise, Weight Loss, and Exercise Plus Weight Loss on Sleep Apnea

Stopped early · Not applicable

Conditions studied: Obstructive Sleep Apnea, Overweight

In brief

Obstructive sleep apnea (OSA) is highly prevalent among Veterans, and is associated with significant mortality and multiple morbidities. Available treatments have had limited effectiveness in treating OSA and alleviating associated morbidity. The investigators' previous research found a reduction in OSA severity of approximately 25% following modest exercise training. That this effect occurred independent of weight loss raises the exciting possibility that exercise combined with weight loss could reduce OSA by at least 50% and have unique health benefits for OSA patients. Following screening and baseline assessments, 90 overweight Veterans ages 18-60 years with OSA will be randomized to one of three 16-week treatments: (1) exercise training; (2) 10 % weight loss; and 3) exercise + weight loss. Changes in OSA and related morbidity will be compared between treatments.

Key facts

Study ID

NCT02721251

Run by

VA Office of Research and Development

People needed

52

Starts

2016-04-01

Expected to finish

2019-09-30

Last updated by the study team

2021-05-06

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Veteran
• 18-65 years of age
• Moderate-severity OSA [[Apnea-hypopnea index (AHI) 15 at screening]
• Overweight/obese
• Physically inactive
• BMI 28
• Sedentary lifestyle (planned activity for purpose of health < 2 days/week)
• Stable weight Not engaged in weight loss study or program
• Stable medications Medications for thyroid, cholesterol, blood pressure, and other conditions at same dose for 2 months
• Capable of signing consent and willing to provide informed consent and accept randomization assignment

You may not qualify if…

• Current OSA treatment Current use of continuous positive airway pressure (PAP), dental devices, etc. for OSA treatment. Past PAP or oral appliances are not exclusions if discontinued 2 months before study
• Significant disease: known or signs/symptoms of cardiovascular, metabolic, or pulmonary disease
• Uncontrolled hypertension: Blood pressure > 159/99 mmHg
• Unable to exercise: musculoskeletal, orthopedic, neuromuscular, or other conditions that do not allow exercise or where exercise is contraindicated
• Any accident attributable to sleepiness in previous 3 years
• Current pregnancy/planning to become pregnant
• Clinically judged unsuitable as evaluated by supervising medical physician

Where it is running

• Phoenix VA Health Care System, Phoenix, AZ — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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