Addressing Sleep Problems in Older Adults

Sleep Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02593981
• Other study ID #: 15-006031
• Status: Withdrawn
• Phase: N/A
• Start date: March 2018
• Est. completion date: April 2019

Study information

• Verified date: December 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. Age = 60 years old at the time of study registration.

2. Individual describes trouble either falling asleep or staying asleep at study entry.

3. Willing to participate in all aspects of the study.

4. Willing to avoid kiwifruit, cherry, and honey for 4 weeks while on this study.

5. 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:

1. Allergic to kiwifruit, cherries, honey, apples, or bananas.

2. Hospitalized or living in a care facility at the time of enrollment.

3. Clinical evidence of active malignant disease (cancer), as per healthcare provider's clinical judgment.

4. Any cancer therapy (for example, chemotherapy, hormonal therapy, radiation, surgery, immunotherapy) in the preceding 3 months.

5. Healthcare provider does not think that study candidate has a specific health problem that precludes participation.

6. Allergy or intolerance of milk products.

7. Women of child bearing potential.

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep
• Sleep Wake Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSQI score	Pittsburgh Sleep Quality Index (PSQI):	28 days