Addressing Sleep Problems in Older Adults | NCT02593981

Studies
Addressing Sleep Problems in Older Adults

NCT02593981

Sponsor

Mayo Clinic

Status

Withdrawn

Last Update Posted

Dec 11, 2018Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Sleep

Interventions

Fruit/Honey drink
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to obtain study agent

Expanded Access Info

Start Date

Mar 2018Estimated

Primary Completion Date

Feb 2019Estimated

Completion Date

Apr 2019Estimated

First Submitted Date

Oct 29, 2015

First Submission Date that Met QC Criteria

Oct 29, 2015

First Posted Date

Nov 2, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2018

Last Update Posted Date

Dec 11, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fruit/Honey Drink	Active Comparator	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
Placebo	Placebo Comparator	Placebo (2 canisters) will be taken orally twice a day. Subjects will consume the placebo drink on days 1 through 28.	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fruit/Honey drink	Dietary Supplement	2 canisters of powder containing fruit/honey mix to be mixed with water and ingested twice a day for 28 days	Fruit/Honey Drink

Measure	Description	Time Frame
PSQI score	Pittsburgh Sleep Quality Index (PSQI):	28 days

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Brent Bauer, MD	Mayo Clinic	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55905	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005638	Fruit

Ancestor Terms

ID	Term
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages

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