Obstructive Sleep ApneaNCT02251574
Effect of a Very Low Calorie and Low Calorie Diet on Moderate to Severe Obstructive Sleep Apnea in Obese Adults
A study testing Low Calorie Diet and Very Low Calorie Diet in people with Obstructive Sleep Apnea, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness of two different weight loss diets on obstructive sleep apnea (OSA) severity. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Low Calorie Diet and Very Low Calorie Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- AHI score of ≥ 5
- Body mass index (BMI) between 30 to 49.9 kg/m2
Who cannot join
- Report serious medical risk such as insulin-dependent diabetes, active cancer, recent cardiac event
- Currently or planning to become pregnant during the next 9 months
- Not weight stable (-4.6 kg) for 3 mos. prior to intake
- Report current participation in a weight reduction program involving diet or PA
- Unwilling to be randomized to 1 of 3 study groups
- Report symptomology of an eating disorder as determined by the Eating Attitudes Test
- Unable to participate in moderate intensity physical activity
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The purpose of this study is to test the effectiveness of two different weight loss diets on obstructive sleep apnea (OSA) severity.
Read the detailed description
Sleep apnea is a sleep disorder in which breathing repeatedly stops and starts during sleep. The most common type is obstructive sleep apnea (OSA), which occurs when the muscles in your throat relax and block your airway during sleep. The most noticeable sign of OSA is snoring. OSA is a risk factor for other chronic conditions like type 2 diabetes, cardiovascular disease, and high blood pressure.
Although anyone can develop OSA, it commonly affects people who are obese. The more someone weighs, the more likely the OSA is to be severe. Weight loss is typically recommended for overweight individuals to help improve OSA. However, not enough research has been done for doctors to be able make specific recommendations to their patients.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Low Calorie Diet, Very Low Calorie Diet, Standard Care
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Calorie DietOther
Weight management program designed around a low calorie diet.
Very Low Calorie DietOther
Weight management program designed around a very low calorie diet.
Standard CareOther
Care provided that would normally be given to people meeting eligibility criteria for this study.
| Study group | Role | What they receive |
|---|---|---|
| Low Calorie Diet | Experimental | Participants will take part in an experimental weight management program involving a low calorie diet (LCD), about 1200-1500 calories per day. Receives: Other: Low Calorie Diet |
| Very Low Calorie Diet | Experimental | Participants will take part in an experimental weight management program involving a low calorie diet (LCD), about 520-800 calories per day. Receives: Other: Very Low Calorie Diet |
| Standard Care | Active comparator | Participants will receive normal care. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Apnea Hypopnea Index (AHI)
The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour.
Measured: Change from Baseline to Month 3
Secondary outcomes (4)
Change in Apnea Hypopnea Index (AHI)
The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour.
Measured: Change from Baseline to Month 9
Change in metabolic syndrome (MetS) risk factors
Risk factors to be measured include waist circumference, triglycerides, HDL-cholesterol, blood pressure, fasting glucose
Measured: Change from Baseline to Month 3 and Month 9
Change in Quality of Life
Participants will complete the Calgary Sleep Apnea Quality of Life Index (SAQLI) that will assess participants response to the intervention/treatment.
Measured: Change from Baseline to Month 3 and Month 9
Change in Daytime Sleepiness
Researchers will administer Epworth Sleepiness Scale. Results will be used to calculate daytime sleepiness changes for each participant.
Measured: Change from Baseline to Month 3 and Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeannine Goetz, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251574
- Sponsor's protocol ID
- STUDY00001418
- Status last verified
- Apr 2018
- First submitted
- 25 Sep 2014
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Very Low Calorie and Low Calorie Diet on Moderate to Severe Obstructive Sleep Apnea in Obese Adults
- ClinicalTrials.gov ID
- NCT02251574
- Acronym / sponsor ID
- STUDY00001418
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 29 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the effectiveness of two different weight loss diets on obstructive sleep apnea (OSA) severity.
Detailed description
Sleep apnea is a sleep disorder in which breathing repeatedly stops and starts during sleep. The most common type is obstructive sleep apnea (OSA), which occurs when the muscles in your throat relax and block your airway during sleep. The most noticeable sign of OSA is snoring. OSA is a risk factor for other chronic conditions like type 2 diabetes, cardiovascular disease, and high blood pressure.
Although anyone can develop OSA, it commonly affects people who are obese. The more someone weighs, the more likely the OSA is to be severe. Weight loss is typically recommended for overweight individuals to help improve OSA. However, not enough research has been done for doctors to be able make specific recommendations to their patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Calorie Diet | Experimental | Other: Low Calorie DietParticipants will take part in an experimental weight management program involving a low calorie diet (LCD), about 1200-1500 calories per day. |
| Very Low Calorie Diet | Experimental | Other: Very Low Calorie DietParticipants will take part in an experimental weight management program involving a low calorie diet (LCD), about 520-800 calories per day. |
| Standard Care | Active comparator | Other: Standard CareParticipants will receive normal care. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- AHI score of ≥ 5
- Body mass index (BMI) between 30 to 49.9 kg/m2
Key exclusion criteria (7 listed)
- Report serious medical risk such as insulin-dependent diabetes, active cancer, recent cardiac event
- Currently or planning to become pregnant during the next 9 months
- Not weight stable (-4.6 kg) for 3 mos. prior to intake
- Report current participation in a weight reduction program involving diet or PA
- Unwilling to be randomized to 1 of 3 study groups
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 |
|---|---|---|
| Low Calorie DietWeight management program designed around a low calorie diet. | Other | Low Calorie Diet |
| Very Low Calorie DietWeight management program designed around a very low calorie diet. | Other | Very Low Calorie Diet |
| Standard CareCare provided that would normally be given to people meeting eligibility criteria for this study. | Other | Standard Care |
Primary outcome
Change in Apnea Hypopnea Index (AHI)
Time frame: Change from Baseline to Month 3
The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour.
4 secondary outcomes
Change in Apnea Hypopnea Index (AHI)
Time frame: Change from Baseline to Month 9
Change in metabolic syndrome (MetS) risk factors
Time frame: Change from Baseline to Month 3 and Month 9
Change in Quality of Life
Time frame: Change from Baseline to Month 3 and Month 9
Change in Daytime Sleepiness
Time frame: Change from Baseline to Month 3 and Month 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
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.
Jeannine Goetz, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Calorie Diet and Very Low Calorie Diet in people with Obstructive Sleep Apnea, run by University of Kansas Medical Center 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 2 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: finished, as of the sponsor's last update on 5 Apr 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Apnea Hypopnea Index (AHI) (time frame: Change from Baseline to Month 3). 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 5 Apr 2018.