Obstructive Sleep ApneaNCT02721251
Influence of Exercise, Weight Loss, and Exercise Plus Weight Loss on Sleep Apnea
A study testing Exercise, Weight Loss and Exercise + Weight Loss in people with Obstructive Sleep Apnea and Overweight, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Overweight
- What is being tested?
- Exercise, Weight Loss and Exercise + Weight Loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2016to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Veteran
- 18-65 years of age
- Moderate-severity OSA [[Apnea-hypopnea index (AHI) 15 at screening]
- Overweight/obese
- Physically inactive
- BMI 28
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, 85012
About this study
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.
Read the detailed description
Rationale: Approximately 15-20% of adults have obstructive sleep apnea (OSA), and evidence indicates that the prevalence of OSA is perhaps twice as high among Veterans. OSA has been clearly linked to increased mortality and multiple morbidities, and undoubtedly contributes to the high prevalence of health problems among Veterans. Current treatments for OSA are not well tolerated, often have limited efficacy, and often do not result in improvements in health. The investigators' recent research demonstrated that 12 weeks of moderate exercise training elicited a reduction of OSA of ~25%, as well as significant improvement in mood, fatigue, quality of life, and cardiovascular health. Interestingly, as with other health benefits of exercise, the investigators' research is consistent with other research showing that exercise can reduce OSA independent of changes in body weight. These studies raise the exciting possibility that exercise training combined with modest weight loss could elicit a chronic reduction in OSA of 50% or more.
Objectives: The investigators' Objective is to compare the effects of 16 weeks of exercise training alone, weight loss alone, and exercise + weight loss on OSA severity and associated morbidity.
Methods: Following extensive screening and baseline assessment, N=90 overweight/obese Veterans (ages 18-60 years) with mild to severe OSA will be randomized to one of three 16-week treatments. (1) Exercise Alone (n=30) will involve training 4 days per week under supervision of a clinical exercise physiologist. It will include aerobic exercise (treadmill, cycling, elliptical) that will gradually increase to 30-45 min on 4 days/wk, as well as resistance exercise (15 min) on 2 days/week. (2) Weight Loss Alone (n=30) will involve a structured meal plan (including some meal replacement with shakes or bars), and weekly counseling designed to elicit a reduction in body weight of 10%. (3) Exercise + Weight Loss (n=30) will involve the same exercise and weight loss interventions as in the other treatments. Outside of the interventions, participants will be asked to maintain their usual exercise and diet habits, as verified, respectively, with actigraphic recording and a 24-hr food recall. Before and after the treatments, participants will undergo 5 days/nights of home-based actigraphic and diary-assessed sleep, and one night of laboratory polysomnographic recording of sleep, including OSA severity. Comorbidity measures will include pre- to post-treatment changes in blood pressure, glucose, insulin, lipids, hemoglobin a1c, body weight/composition, and inflammation (e.g., CRP, IL-6). Also measured will be monthly changes in self-reports of sleep quality, functional outcomes of sleepiness (FOSQ), and snoring symptoms. A 3-month follow-up will include home assessment of OSA, as well as sleep quality, FOSQ, and snoring. Mediation analysis will explore whether improvements in OSA are mediated by changes in percent of deep sleep, body weight, trunk body fat percent, trunk total mass, respiratory muscle strength, and upper airway obstruction assessed in the laboratory.
Implications for Future Research. Demonstration of a reduction of OSA by 50% would result in extensive subsequent studies. These would likely include studies of dose-response effects; comparisons of different modes of exercise; studies of the feasibility of telemedicine approaches to the interventions; comparative efficacy studies vs. PAP; further mechanistic studies, for example, of upper airway collapsibility and composition (e.g, via MRI); and studies of other positive health outcomes, such as extensive heart imaging.
- Conditions
- Obstructive Sleep Apnea, Overweight
- Being tested
- Exercise, Weight Loss, Exercise + Weight Loss
- Keywords
- exercise, weight loss, sleep apnea
- Medical subject headings
- Sleep Apnea, Obstructive, Overweight, Motor Activity, Weight Loss, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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)
Weight LossBehavioural
16 week. the goal is 10% weight loss.
Exercise + Weight LossBehavioural
Combined exercise and weight loss components of the other arms
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Weight Loss |
| Exercise + Weight Loss | Experimental | Combined components of the exercise and weight loss treatments Receives: Behavioral: Exercise + Weight Loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to the end of the study (16-week intervention)
Secondary outcomes (7)
Functional Outcomes of Sleepiness Questionnaire (FOSQ)
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
Measured: Change from baseline to the end of the study (16-week intervention)
Snoring Severity Scale
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
Measured: Change from baseline to the end of the study (16-week intervention)
Pittsburgh Sleep Quality Index (PSQI)
Commonly used metric of sleep quality. Baseline minus end of study. Positive value indicates improvement.
Minimum score: 0 Maximum score: 21
Measured: Change from baseline to the end of the study (16-week intervention)
Blood Pressure
Blood pressure
Measured: Change from baseline to the end of the study (16-week intervention)
Body Weight
Fasting body weight. Weight change (kg) beginning to end of study (positive valuate = decrease)
Measured: Change from baseline to the end of the study (16-week intervention)
Percent Body Fat Assessed With Dual-energy X-reay Absorptiometry (DEXA)
Percent body fat assessed with DEXA. Change in percent body fat - positive value represents a decrease.
Measured: Change from baseline to the end of the study (16-week intervention)
C-reactive Protein (CRP)
Measure of inflammation
Measured: Change from baseline to the end of the study (16-week intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study start1 Apr 2016
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Why it stopped: Behind enrollment targets
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Shawn D. Youngstedt, PhD, Principal investigator, Phoenix VA Health Care System, Phoenix, AZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721251
- Sponsor's protocol ID
- CLNB-012-14S
- Status last verified
- Apr 2021
- First submitted
- 17 Feb 2016
- Last updated
- 6 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Exercise, Weight Loss, and Exercise Plus Weight Loss on Sleep Apnea
- ClinicalTrials.gov ID
- NCT02721251
- Acronym / sponsor ID
- CLNB-012-14S
- Conditions
- Obstructive Sleep Apnea, Overweight
- Keywords
- exercise, weight loss, sleep apnea
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Behind enrollment targets
- Enrolment
- 52 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 29 Mar 2016 (estimated)
- Results
- Posted 6 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale: Approximately 15-20% of adults have obstructive sleep apnea (OSA), and evidence indicates that the prevalence of OSA is perhaps twice as high among Veterans. OSA has been clearly linked to increased mortality and multiple morbidities, and undoubtedly contributes to the high prevalence of health problems among Veterans. Current treatments for OSA are not well tolerated, often have limited efficacy, and often do not result in improvements in health. The investigators' recent research demonstrated that 12 weeks of moderate exercise training elicited a reduction of OSA of ~25%, as well as significant improvement in mood, fatigue, quality of life, and cardiovascular health. Interestingly, as with other health benefits of exercise, the investigators' research is consistent with other research showing that exercise can reduce OSA independent of changes in body weight. These studies raise the exciting possibility that exercise training combined with modest weight loss could elicit a chronic reduction in OSA of 50% or more.
Objectives: The investigators' Objective is to compare the effects of 16 weeks of exercise training alone, weight loss alone, and exercise + weight loss on OSA severity and associated morbidity.
Methods: Following extensive screening and baseline assessment, N=90 overweight/obese Veterans (ages 18-60 years) with mild to severe OSA will be randomized to one of three 16-week treatments. (1) Exercise Alone (n=30) will involve training 4 days per week under supervision of a clinical exercise physiologist. It will include aerobic exercise (treadmill, cycling, elliptical) that will gradually increase to 30-45 min on 4 days/wk, as well as resistance exercise (15 min) on 2 days/week. (2) Weight Loss Alone (n=30) will involve a structured meal plan (including some meal replacement with shakes or bars), and weekly counseling designed to elicit a reduction in body weight of 10%. (3) Exercise + Weight Loss (n=30) will involve the same exercise and weight loss interventions as in the other treatments. Outside of the interventions, participants will be asked to maintain their usual exercise and diet habits, as verified, respectively, with actigraphic recording and a 24-hr food recall. Before and after the treatments, participants will undergo 5 days/nights of home-based actigraphic and diary-assessed sleep, and one night of laboratory polysomnographic recording of sleep, including OSA severity. Comorbidity measures will include pre- to post-treatment changes in blood pressure, glucose, insulin, lipids, hemoglobin a1c, body weight/composition, and inflammation (e.g., CRP, IL-6). Also measured will be monthly changes in self-reports of sleep quality, functional outcomes of sleepiness (FOSQ), and snoring symptoms. A 3-month follow-up will include home assessment of OSA, as well as sleep quality, FOSQ, and snoring. Mediation analysis will explore whether improvements in OSA are mediated by changes in percent of deep sleep, body weight, trunk body fat percent, trunk total mass, respiratory muscle strength, and upper airway obstruction assessed in the laboratory.
Implications for Future Research. Demonstration of a reduction of OSA by 50% would result in extensive subsequent studies. These would likely include studies of dose-response effects; comparisons of different modes of exercise; studies of the feasibility of telemedicine approaches to the interventions; comparative efficacy studies vs. PAP; further mechanistic studies, for example, of upper airway collapsibility and composition (e.g, via MRI); and studies of other positive health outcomes, such as extensive heart imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercise16 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 |
| Weight Loss | Experimental | Behavioral: Weight Loss16 week intervention with a goal weight loss of 10%, accomplished with caloric and fat restriction, weekly sessions with a nutritionist, and some meal replacement |
| Exercise + Weight Loss | Experimental | Behavioral: Exercise + Weight LossCombined components of the exercise and weight loss treatments |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Veteran
- 18-65 years of age
- Moderate-severity OSA [[Apnea-hypopnea index (AHI) 15 at screening]
- Overweight/obese
- Physically inactive
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise16 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) | Behavioural | Exercise |
| Weight Loss16 week. the goal is 10% weight loss. | Behavioural | Weight Loss |
| Exercise + Weight LossCombined exercise and weight loss components of the other arms | Behavioural | Exercise + Weight Loss |
Primary outcome
Apnea-hypopnea Index (AHI)
Time frame: Change from baseline to the end of the study (16-week intervention)
Common criterion for obstructive sleep apnea: number of apnea and hypopnea episodes per hour of sleep. Baseline-end - positive value indicates a reduction.
7 secondary outcomes
Functional Outcomes of Sleepiness Questionnaire (FOSQ)
Time frame: Change from baseline to the end of the study (16-week intervention)
Snoring Severity Scale
Time frame: Change from baseline to the end of the study (16-week intervention)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from baseline to the end of the study (16-week intervention)
Blood Pressure
Time frame: Change from baseline to the end of the study (16-week intervention)
Body Weight
Time frame: Change from baseline to the end of the study (16-week intervention)
Percent Body Fat Assessed With Dual-energy X-reay Absorptiometry (DEXA)
Time frame: Change from baseline to the end of the study (16-week intervention)
C-reactive Protein (CRP)
Time frame: Change from baseline to the end of the study (16-week intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shawn D. Youngstedt, PhD principal investigator
Phoenix VA Health Care System, Phoenix, AZ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Weight Loss and Exercise + Weight Loss in people with Obstructive Sleep Apnea and Overweight, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-hypopnea Index (AHI) (time frame: Change from baseline to the end of the study (16-week intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.