Effect of CPAP Treatment on Glycemic Control in Gestational Diabetes: A Pilot Randomized-Controlled Trial
The Effect of Continuous Positive Airway Pressure (CPAP) Treatment on Glycemic Control in Gestational Diabetes: A Pilot Randomized-Controlled Trial
연구 개요
상세 설명
Gestational diabetes (GDM), defined as glucose intolerance that is first recognized during pregnancy, is associated with adverse maternal and fetal outcomes. Sleep-disordered breathing (SDB) is characterized by breathing pauses during sleep leading to recurrent arousals and intermittent hypoxia. The resulting increases in sympathetic drive, cortisol and inflammation have been shown to lead to glucose dysregulation. In that SDB is prevalent during pregnancy, SDB may represent a novel risk factor for GDM, as suggested by recent observational studies. No interventional studies evaluating the effects of SDB treatment on GDM outcomes have yet been published.
General Objective: To perform a pilot study to assess the feasibility of conducting a randomized-controlled trial using continuous positive airway pressure (CPAP) to evaluate the effects of SDB treatment on maternal-fetal outcomes in GDM.
Primary Aim of Pilot Study: 1) To assess CPAP adherence in pregnant patients with GDM. Secondary Aims: 2) To assess recruitment and retention rates over ~2 months of treatment 3) To assess adequacy of nasal dilator strips as the control intervention 4) To measure maternal glucose levels to determine sample size calculations for a future large-scale multi-site randomized-controlled trial.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Quebec
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Montreal, Quebec, 캐나다, H4A2Y3
- McGill University Health Centre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Pregnant women aged ≥ 18 y referred to the GDM clinic at the McGill University Health Centre
- >20 weeks and <34 weeks gestational age at time of recruitment
- Gestational diabetes
- Sleep-disordered breathing (SDB)
Exclusion Criteria:
- Pre-gestational type 1 or type 2 diabetes
- Multiple pregnancy
- Conception by IVF
- Prior treatment for SDB
- severe medical illness
- Severe SDB (AHI >30) and Epworth Sleepiness Scale >15 or oxygen desaturation index >30 or sustained hypoxia < 80%
- Habitual sleep duration on average less than 5 hours/night (determined by actigraphy)
- Cigarette smoking, alcohol consumption or illicit drug use
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: 양압기
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Continuous Positive Airway Pressure
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다른: Nasal dilator strip
Control
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Nasal dilator strip to be worn nightly
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Average nightly hours of CPAP use
기간: Up to 8 weeks
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Calculated over the course of pregnancy, with objective measurement from CPAP device download.
CPAP will be initiated at time of diagnosis of sleep apnea after GDM diagnosis, and up until delivery of the baby (expected duration of 6-8 weeks)
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Up to 8 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Recruitment and retention rates in trial
기간: At completion of study (prior to delivery of baby)
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At completion of study (prior to delivery of baby)
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Maternal glucose levels
기간: Throughout pregnancy until delivery
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Continuous glucose monitoring and capillary blood glucose checks
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Throughout pregnancy until delivery
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공동 작업자 및 조사자
간행물 및 유용한 링크
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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