Addressing Sleep Problems in Older Adults
To Sleep, Perchance to Dream: A Randomized, Placebo-Controlled Study to Test a Fruit/Honey-Based Foodstuff for Sleep Problems in Older Adults
As many as 57% of older adults complain of major disruption of sleep, 29% struggle to fall asleep and 19% complain of early-morning awakening. The implications of this sleep deprivation are sobering, particularly among older individuals.
The primary goal of this study is to determine whether a palatable foodstuff which contains a fruit/honey drink and which is taken every evening before bedtime leads to improved sleep in community-living individuals with sleep problems.
연구 개요
상세 설명
This is a randomized, placebo-controlled double-blinded pilot study to explore the use of a fruit/honey drink product for improving sleep in older adults. The purpose of this study is to estimate the effects of a fruit/honey drink using various assessment tools when used as short-term intervention.
This trial proposes to enroll a total of 60 community based older adults. All study patients will be instructed to take the study product every day for 28 days. During which time, study subjects will return weekly to complete study visits for a total of 4 visits.
연구 유형
단계
- 해당 없음
연락처 및 위치
연구 장소
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Minnesota
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age ≥ 60 years old at the time of study registration.
- Individual describes trouble either falling asleep or staying asleep at study entry.
- Willing to participate in all aspects of the study.
- Willing to avoid kiwifruit, cherry, and honey for 4 weeks while on this study.
- Willing to avoid changes to current sleep medications (may use a stable dose of a currently prescribe sleep medication during the first 4 weeks after stating the intervention).
Exclusion Criteria:
- Allergic to kiwifruit, cherries, honey, apples, or bananas.
- Hospitalized or living in a care facility at the time of enrollment.
- Clinical evidence of active malignant disease (cancer), as per healthcare provider's clinical judgment.
- Any cancer therapy (for example, chemotherapy, hormonal therapy, radiation, surgery, immunotherapy) in the preceding 3 months.
- Healthcare provider does not think that study candidate has a specific health problem that precludes participation.
- Allergy or intolerance of milk products.
- Women of child bearing potential.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Fruit/Honey Drink
Fruit/Honey Drink (2 canisters) will be taken orally twice a day.
Subjects will consume the drink on days 1 through 28.
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2 canisters of powder containing fruit/honey mix to be mixed with water and ingested twice a day for 28 days
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위약 비교기: Placebo
Placebo (2 canisters) will be taken orally twice a day.
Subjects will consume the placebo drink on days 1 through 28.
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2 canisters of Placebo powder containing non-active ingredient to be mixed with water and ingested twice a day for 28 days
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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PSQI score
기간: 28 days
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Pittsburgh Sleep Quality Index (PSQI):
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28 days
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
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. .