Last reviewed · How we verify
Influence of Exercise, Weight Loss, and Exercise Plus Weight Loss on Sleep Apnea
NA trial testing Exercise in Obstructive Sleep Apnea in 52 participants. Terminated before completion.
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 52 |
| Start date | 1 April 2016 |
| Primary completion | 30 September 2019 |
| Estimated completion | 30 September 2019 |
| Sites | 1 location across United States |
VA Office of Research and Development — full company profile →
Adults 18 to 60, any sex, with Obstructive Sleep Apnea or Overweight. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Common criterion for obstructive sleep apnea: number of apnea and hypopnea episodes per hour of sleep. Baseline-end - positive value indicates a reduction.
| Group | Value | 95% CI |
|---|---|---|
| Weight Loss | 17.8 | ± 26.9 |
| Exercise | -4.3 | ± 8.7 |
| Exercise + Weight Loss | -10.7 | ± 7.0 |
Measures impairments in functioning associated with sleepiness. Baseline minus end of study value. Positive value indicates improvement; negative value indicates worsening. Minimum score on scale: 0 Maximum score: 120
| Group | Value | 95% CI |
|---|---|---|
| Weight Loss | -22.7 | ± 14.1 |
| Exercise | -13.6 | ± 19.1 |
| Exercise + Weight Loss | -0.33 | ± 41.0 |
Questionnaire that measures severity of snoring with a questionnaire. A positive value indicates improvement; a negative value indicates worsening. Minimum score: 0 Maximum score: 9
| Group | Value | 95% CI |
|---|---|---|
| Weight Loss | 2.3 | ± 3.9 |
| Exercise | 1.0 | ± 2.2 |
| Exercise + Weight Loss | 0.3 | ± 2.9 |
Commonly used metric of sleep quality. Baseline minus end of study. Positive value indicates improvement. Minimum score: 0 Maximum score: 21
| Group | Value | 95% CI |
|---|---|---|
| Weight Loss | 0.9 | ± 0.6 |
| Exercise | -0.7 | ± 0.6 |
| Exercise + Weight Loss | 1.0 | ± 2.6 |
Fasting body weight. Weight change (kg) beginning to end of study (positive valuate = decrease)
| Group | Value | 95% CI |
|---|---|---|
| Weight Loss | 5.0 | ± 6.9 |
| Exercise | 0.2 | ± 4.7 |
| Exercise + Weight Loss | 8.0 | ± 10.3 |
Percent body fat assessed with DEXA. Change in percent body fat - positive value represents a decrease.
| Group | Value | 95% CI |
|---|---|---|
| Weight Loss | 0.6 | ± 0.4 |
| Exercise | 0.8 | ± 0.9 |
| Exercise + Weight Loss | 1.6 | ± 0.3 |
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.
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02721251.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing