Sleep Apnea
Conditions
Keywords
Sleep apnea, Sleep symptoms, Quality of Life
Brief summary
This project is investigating whether both moderate-intensity physical activity and dietary weight loss will independently reduce sleep apnea symptoms and improve quality of life.
Detailed description
Background/Rationale: Obstructive sleep apnea/hypopnea (OSAH) is a common chronic disease that is associated with daytime sleepiness, impaired health-related quality of life (QOL), and increased risk of hypertension and cardiovascular disease. The most common treatment is continuous positive airway pressure (CPAP), although adherence to CPAP is poor in more than one-third of patients. Weight loss can clearly lessen the severity of OSAH, but although short-term dietary weight loss can often be achieved it is difficult to maintain. Regular aerobic exercise is associated with a lower prevalence of OSAH in observational studies after adjustment for body habitus, and in two small clinical trials moderate exercise was associated with a substantial decrease in OSAH severity despite little or no weight loss. Demonstrating that dietary weight loss and moderate physical activity, promoted in the home setting, independently improve OSAH severity will have a major impact on the therapeutic approach to OSAH, a disease that is highly prevalent in the VA population. Objective: The investigators hypothesize that both moderate-intensity physical activity and dietary weight loss will independently reduce OSAH severity and improve QOL. Methods: The proposed study is a randomized clinical trial designed to test the independent effects of the physical activity and diet interventions, with an attention control intervention for subjects not assigned to either active intervention. Subjects will be male and female Veterans with a BMI over 24 kg/m2, with a physician diagnosis of OSAH and apnea-hypopnea index (AHI) \>10/hr. The interventions will last six months.
Interventions
BEHAVIORALPhysical activity
Moderate-intensity physical activity
BEHAVIORALDiet
Dietary weight loss
BEHAVIORALHealth education
Attention control intervention
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Physician diagnosis of sleep apnea * Apnea-hypopnea index \>10/hr * BMI over 24 kg/m2
Exclusion criteria
* Angina pectoris * History of myocardial infarction within 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change Over 6 Months in Epworth Sleepiness Scale Score | baseline and 6 months | Epworth Sleepiness Scale score, change in score from baseline to 6 months. Total scores range from 0-24, where higher scores indicate more sleepiness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change Over 6 Months in Quality of Life | baseline and 6 months | Quality of life as assessed by the Functional Outcomes of Sleep Questionnaire, change from baseline to 6 months. The potential range of scores for the Functional Outcomes of Sleep total score is 5-20 where higher scores indicate better quality of life. The total score is the sum of the 5 subscale scores (general productivity, social outcome, activity level, vigilance, intimate relationships), which are weighted means ranging from 1-4. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Physical Activity Physical activity
Physical activity: Moderate-intensity physical activity | 46 |
| Diet Diet
Diet: Dietary weight loss | 42 |
| Health Education Health education
Health education: Attention control intervention | 38 |
| Combined Physical Activity/Diet Combined physical activity and diet | 43 |
| Total | 169 |
Baseline characteristics
| Characteristic | Physical Activity | Diet | Health Education | Combined Physical Activity/Diet | Total |
|---|---|---|---|---|---|
| Age, Continuous | 61.8 years STANDARD_DEVIATION 9 | 60.5 years STANDARD_DEVIATION 8.7 | 59.1 years STANDARD_DEVIATION 11 | 56.3 years STANDARD_DEVIATION 10 | 59.5 years STANDARD_DEVIATION 9.8 |
| Gender Female | 2 Participants | 0 Participants | 0 Participants | 3 Participants | 5 Participants |
| Gender Male | 44 Participants | 42 Participants | 38 Participants | 40 Participants | 164 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 46 | 0 / 42 | 0 / 38 | 0 / 43 |
| serious Total, serious adverse events | 0 / 46 | 0 / 42 | 0 / 38 | 0 / 43 |
Outcome results
Primary
Change Over 6 Months in Epworth Sleepiness Scale Score
Epworth Sleepiness Scale score, change in score from baseline to 6 months. Total scores range from 0-24, where higher scores indicate more sleepiness.
Time frame: baseline and 6 months
Population: Two participants did not complete the questionnaire and therefore had missing Epworth Sleepiness Scale scores. One participant in Diet arm and one participant in Health education arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Activity | Change Over 6 Months in Epworth Sleepiness Scale Score | -0.23 units on a scale | Standard Error 0.69 |
| Diet | Change Over 6 Months in Epworth Sleepiness Scale Score | -1.05 units on a scale | Standard Error 0.38 |
| Health Education | Change Over 6 Months in Epworth Sleepiness Scale Score | 0.43 units on a scale | Standard Error 0.66 |
| Combined Physical Activity/Diet | Change Over 6 Months in Epworth Sleepiness Scale Score | -2.62 units on a scale | Standard Error 0.59 |
Secondary
Change Over 6 Months in Quality of Life
Quality of life as assessed by the Functional Outcomes of Sleep Questionnaire, change from baseline to 6 months. The potential range of scores for the Functional Outcomes of Sleep total score is 5-20 where higher scores indicate better quality of life. The total score is the sum of the 5 subscale scores (general productivity, social outcome, activity level, vigilance, intimate relationships), which are weighted means ranging from 1-4.
Time frame: baseline and 6 months
Population: Two participants did not complete the questionnaire and therefore had missing Functional Outcomes of Sleep Questionnaire scores. One participant in Diet arm and one participant in Health education arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Activity | Change Over 6 Months in Quality of Life | 0.24 units on a scale | Standard Error 0.44 |
| Diet | Change Over 6 Months in Quality of Life | 0.15 units on a scale | Standard Error 0.24 |
| Health Education | Change Over 6 Months in Quality of Life | -0.33 units on a scale | Standard Error 0.28 |
| Combined Physical Activity/Diet | Change Over 6 Months in Quality of Life | 1.24 units on a scale | Standard Error 0.42 |