Effect of a Very Low Calorie and Low Calorie Diet on Moderate to Severe Obstructive Sleep Apnea in Obese Adults
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Kansas
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Kansas City, Kansas, 미국, 66160
- University of Kansas Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- AHI score of ≥ 5
- Body mass index (BMI) between 30 to 49.9 kg/m2
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Low Calorie Diet
Participants will take part in an experimental weight management program involving a low calorie diet (LCD), about 1200-1500 calories per day.
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Weight management program designed around a low calorie diet.
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실험적: Very Low Calorie Diet
Participants will take part in an experimental weight management program involving a low calorie diet (LCD), about 520-800 calories per day.
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Weight management program designed around a very low calorie diet.
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활성 비교기: Standard Care
Participants will receive normal care.
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Care provided that would normally be given to people meeting eligibility criteria for this study.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Apnea Hypopnea Index (AHI)
기간: Change from Baseline to Month 3
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The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour.
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Change from Baseline to Month 3
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Apnea Hypopnea Index (AHI)
기간: Change from Baseline to Month 9
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The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour.
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Change from Baseline to Month 9
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Change in metabolic syndrome (MetS) risk factors
기간: Change from Baseline to Month 3 and Month 9
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Risk factors to be measured include waist circumference, triglycerides, HDL-cholesterol, blood pressure, fasting glucose
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Change from Baseline to Month 3 and Month 9
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Change in Quality of Life
기간: Change from Baseline to Month 3 and Month 9
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Participants will complete the Calgary Sleep Apnea Quality of Life Index (SAQLI) that will assess participants response to the intervention/treatment.
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Change from Baseline to Month 3 and Month 9
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Change in Daytime Sleepiness
기간: Change from Baseline to Month 3 and Month 9
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Researchers will administer Epworth Sleepiness Scale.
Results will be used to calculate daytime sleepiness changes for each participant.
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Change from Baseline to Month 3 and Month 9
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jeannine Goetz, PhD, University of Kansas Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00001418
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