Back to resultsAddressing Sleep Problems in Older Adults
Primary Purpose
Sleep
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fruit/Honey drink
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sleep focused on measuring sleep, fruit, honey, geriatric
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Fruit/Honey Drink
Placebo
Arm Description
Fruit/Honey Drink (2 canisters) will be taken orally twice a day. Subjects will consume the drink on days 1 through 28.
Placebo (2 canisters) will be taken orally twice a day. Subjects will consume the placebo drink on days 1 through 28.
Outcomes
Primary Outcome Measures
PSQI score
Pittsburgh Sleep Quality Index (PSQI):
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02593981
Brief Title
Addressing Sleep Problems in Older Adults
Official Title
To Sleep, Perchance to Dream: A Randomized, Placebo-Controlled Study to Test a Fruit/Honey-Based Foodstuff for Sleep Problems in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to obtain study agent
Study Start Date
March 2018 (Anticipated)
Primary Completion Date
February 2019 (Anticipated)
Study Completion Date
April 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep
Keywords
sleep, fruit, honey, geriatric
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fruit/Honey Drink
Arm Type
Active Comparator
Arm Description
Fruit/Honey Drink (2 canisters) will be taken orally twice a day. Subjects will consume the drink on days 1 through 28.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (2 canisters) will be taken orally twice a day. Subjects will consume the placebo drink on days 1 through 28.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fruit/Honey drink
Intervention Description
2 canisters of powder containing fruit/honey mix to be mixed with water and ingested twice a day for 28 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
2 canisters of Placebo powder containing non-active ingredient to be mixed with water and ingested twice a day for 28 days
Primary Outcome Measure Information:
Title
PSQI score
Description
Pittsburgh Sleep Quality Index (PSQI):
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brent Bauer, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Addressing Sleep Problems in Older Adults
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