- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02068703
Sleep Enhancing Tools: Pilot Study
Use of Sleep Enhancing Tools Impact on Self-Reported Sleep Survey
연구 개요
상세 설명
A randomized, clinical pilot to trial the effect of sleep tools on patients' perception of sleep within the hospital setting.
We propose to conduct this pilot study to improve subjective symptoms of sleep deprivation in non-ICU hospitalized subjects by performing a brief intervention, easily performed at the point of care. Given the heterogeneity of hospitalized patients with varying ages, co-morbidities and other factors (such as pain and fatigue), we felt that an initial pilot study should focus on acceptability of three sleep aids (ear plugs, eye masks and white noise machine) among hospitalized non-ICU patients. Patients will be able to choose which aid they use and will be allowed to change aids during their hospital stay.
The primary outcomes of this study will be 1) improvement in perceived sleep quality as measured by PROMIS, a validated patient-reported outcome information system and 2) quality of care measures (length of stay, medication use and participation in therapy sessions).
PROMIS (Patient Reported Outcomes Measurement Information System) is an NIH sponsored health survey tool.
Information on characteristics (both patient and environment) including demographics, illness severity, number of medications, specific medications (such as sedatives and pain medications) will be collected to examine which predictors of improved perception of sleep quality correlate with use of sleep aids. This study is intended to focus on modifying the environment at the patient level rather than addressing the sources of environmental hospital noise.
Our study has the potential to impact this field with a preventative education based intervention, using simple tools in the non-ICU setting. It is important to understand this is not a study measuring sleep objectively but whether hospitalized patients perceive they sleep better if sleep aids are used.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- UMichigan
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Admitted to a private room in the hospital
- Speak and read english
- expected length of stay > 2 days
Exclusion Criteria:
- Hearing aids
- sleep apnea using positive airway pressure therapy
- medically or behaviorally unstable
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Intervention
Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep PLUS a demonstration of tools (face mask, ear plugs and white noise machine) to improve sleep.
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Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep WITHOUT a demonstration of tools to improve sleep.
Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep PLUS a demonstration of tools to improve sleep.
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위약 비교기: Inert Control
Same 10 min time exposure and tool delivery to subjects in this arm WITHOUT demonstration.
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Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep WITHOUT a demonstration of tools to improve sleep.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Aggregate change in sleep /pain / fatigue scores on Patient Reported Outcomes Measurement Information System (PROMIS) survey sampled in hospital from baseline to day 3 between study groups
기간: Baseline to day 3
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Change from baseline in sleep / pain / fatigue scores on PROMIS survey in the hospital.
Each score ranges from 1-5, 1 equals not at all; 5 equals Very much.
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Baseline to day 3
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Effect of use of sleep tool devices on length of stay
기간: number hospital days between administration of tool and hospital discharge
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Whether the intervention of demonstrating use of sleep enhancing tools will translate into reduced length of hospital stay
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number hospital days between administration of tool and hospital discharge
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Effect of sleep enhancing tools on medication use
기간: baseline to day 3
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Whether the intervention of demonstrating use of sleep enhancing tools will translate into reduced use of sleep or pain medication
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baseline to day 3
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Effect of sleep enhancing tools on participation in Occupational therapy
기간: baseline to day 3
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Whether the intervention of using sleep enhancing tools will translate into increased number of days participating in therapy during the study
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baseline to day 3
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공동 작업자 및 조사자
수사관
- 수석 연구원: Peter Farrehi, MD, University of Michigan
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- HUM00075628
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. .
Sleep Education Presentation에 대한 임상 시험
-
Leiden UniversityBioClock Consortium; Caring Univeristies완전한
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