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

NCT02721251 | Terminated Results

• 1 other identifier: CLNB-012-14S
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea; Overweight

Keywords

exercise; weight loss; sleep apnea

Outcome Measures

Primary Outcomes (1)

• Apnea-hypopnea Index (AHI)

  Common criterion for obstructive sleep apnea: number of apnea and hypopnea episodes per hour of sleep. Baseline-end - positive value indicates a reduction.

  Change from baseline to the end of the study (16-week intervention)

Secondary Outcomes (7)

• Functional Outcomes of Sleepiness Questionnaire (FOSQ)

  Change from baseline to the end of the study (16-week intervention)

• Snoring Severity Scale

  Change from baseline to the end of the study (16-week intervention)

• Pittsburgh Sleep Quality Index (PSQI)

  Change from baseline to the end of the study (16-week intervention)

• Blood Pressure

  Change from baseline to the end of the study (16-week intervention)

• Body Weight

  Change from baseline to the end of the study (16-week intervention)

Study Arms (3)

Exercise

EXPERIMENTAL

16 week intervention, building up to 30-45 minutes of aerobic exercise 4 days per week, and 15 min of resistance exercise 2 days per week

Behavioral: Exercise

Weight Loss

EXPERIMENTAL

16 week intervention with a goal weight loss of 10%, accomplished with caloric and fat restriction, weekly sessions with a nutritionist, and some meal replacement

Behavioral: Weight Loss

Exercise + Weight Loss

EXPERIMENTAL

Combined components of the exercise and weight loss treatments

Behavioral: Exercise + Weight Loss

Interventions

Exercise BEHAVIORAL

16 weeks. 4 days per week of aerobic exercise; 45 min for 2 days and for 30 min for two days. 2 days per week of resistance exercise for 15 min (coinciding with the days involving 30 min of aerobic exercise)

Exercise

Weight Loss BEHAVIORAL

16 week. the goal is 10% weight loss.

Weight Loss

Exercise + Weight Loss BEHAVIORAL

Combined exercise and weight loss components of the other arms

Exercise + Weight Loss

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Veteran
• 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:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Phoenix VA Health Care System, Phoenix, AZ

Phoenix, Arizona, 85012, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Overweight; Motor Activity; Weight Loss; Sleep Apnea Syndromes

Interventions

Exercise

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Body Weight Changes

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: David Thompson
• Organization: VA

david.thompson4@va.gov

602-496-0242

Study Officials

• Shawn D. Youngstedt, PhD

  Phoenix VA Health Care System, Phoenix, AZ

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: March 29, 2016
• Study Start: April 1, 2016
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: May 6, 2021
• Results First Posted: May 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)