Effect of a Very Low Calorie and Low Calorie Diet on Moderate to Severe Obstructive Sleep Apnea in Obese Adults
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Kansas
-
Kansas City、Kansas、アメリカ、66160
- University of Kansas Medical Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
Weight management program designed around a low calorie diet.
|
|
実験的：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.
|
Weight management program designed around a very low calorie diet.
|
|
アクティブコンパレータ：Standard Care
Participants will receive normal care.
|
Care provided that would normally be given to people meeting eligibility criteria for this study.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Apnea Hypopnea Index (AHI)
時間枠：Change from Baseline to Month 3
|
The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour.
|
Change from Baseline to Month 3
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Apnea Hypopnea Index (AHI)
時間枠：Change from Baseline to Month 9
|
The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour.
|
Change from Baseline to Month 9
|
|
Change in metabolic syndrome (MetS) risk factors
時間枠：Change from Baseline to Month 3 and Month 9
|
Risk factors to be measured include waist circumference, triglycerides, HDL-cholesterol, blood pressure, fasting glucose
|
Change from Baseline to Month 3 and Month 9
|
|
Change in Quality of Life
時間枠：Change from Baseline to Month 3 and Month 9
|
Participants will complete the Calgary Sleep Apnea Quality of Life Index (SAQLI) that will assess participants response to the intervention/treatment.
|
Change from Baseline to Month 3 and Month 9
|
|
Change in Daytime Sleepiness
時間枠：Change from Baseline to Month 3 and Month 9
|
Researchers will administer Epworth Sleepiness Scale.
Results will be used to calculate daytime sleepiness changes for each participant.
|
Change from Baseline to Month 3 and Month 9
|
協力者と研究者
捜査官
- 主任研究者：Jeannine Goetz, PhD、University of Kansas Medical Center
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。