Addressing Sleep Problems in Older Adults

Sponsor

Mayo Clinic (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02593981

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep	Dietary Supplement: Fruit/Honey drink Dietary Supplement: Placebo	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Mar 1, 2018

Anticipated Primary Completion Date :

Feb 1, 2019

Anticipated Study Completion Date :

Apr 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Dietary Supplement: Fruit/Honey drink 2 canisters of powder containing fruit/honey mix to be mixed with water and ingested twice a day for 28 days
Placebo Comparator: Placebo Placebo (2 canisters) will be taken orally twice a day. Subjects will consume the placebo drink on days 1 through 28.	Dietary Supplement: Placebo 2 canisters of Placebo powder containing non-active ingredient to be mixed with water and ingested twice a day for 28 days

Arm

Intervention/Treatment

Active Comparator: 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.

Dietary Supplement: Fruit/Honey drink

2 canisters of powder containing fruit/honey mix to be mixed with water and ingested twice a day for 28 days

Placebo Comparator: Placebo

Placebo (2 canisters) will be taken orally twice a day. Subjects will consume the placebo drink on days 1 through 28.

Dietary Supplement: Placebo

2 canisters of Placebo powder containing non-active ingredient to be mixed with water and ingested twice a day for 28 days

Outcome Measures

Primary Outcome Measures

PSQI score [28 days]
Pittsburgh Sleep Quality Index (PSQI):

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.