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Sleep Well 24 (SWELL24) Healthy Sleep-Wake Behaviors in Older Adults (SWELL24)

Primary Purpose

Insomnia Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
education and coaching on developing healthy nighttime sleep and daytime activity behaviors
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insomnia Disorder focused on measuring sleep-wake patterns, poor sleep

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 65 or over One or more outpatient primary care visits to Wake Forest Baptist Health in the prior 12 months Meets diagnostic criteria for Insomnia Disorder Less than 30 minutes of daily activity or less than 150 minutes total weekly activity for one month or longer, as reported on brief telephone screener Able to ambulate safely (with or without an assistive device) Able to follow study directions Able to communicate and follow study instructions English speaking Exclusion Criteria: Untreated organic sleep disorder (e.g., central or obstructive sleep apnea, restless leg syndrome) Serious or unstable medical or psychiatric condition that would prevent participation in a behavioral intervention (e.g., terminal illness, uncontrolled psychiatric disorder, substance abuse disorder) Lack of decision-making capacity, as documented in medical record Referred to institutional care and/or currently residing in a nursing home or other residential facility

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

education and coaching on developing healthy nighttime sleep and daytime activity behaviors

Arm Description

The intervention includes a four-session, in-person program delivered by a Master's-level provider. Each individual session will be approximately 30-45 minutes in length. Each session will include education and coaching on developing healthy nighttime sleep and daytime activity behaviors.

Outcomes

Primary Outcome Measures

Sleep efficiency
Total time asleep/total time in bed, per wrist actigraph

Secondary Outcome Measures

Insomnia severity scores
Insomnia Severity Index (ISI) is a 7-item validated, self-report questionnaire used to evaluate insomnia severity. Scores range from 0 - 28, higher scores indicate more severe insomnia symptom severity.
total daytime activity
Daily activity (total count), per wrist actigraph
daytime consequences
per self-reported assessment, daily diary

Full Information

First Posted
March 10, 2023
Last Updated
August 28, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05780983
Brief Title
Sleep Well 24 (SWELL24) Healthy Sleep-Wake Behaviors in Older Adults
Acronym
SWELL24
Official Title
Sleep Well 24 (SWELL24): Promoting Healthy Sleep-wake Behaviors Across a 24-hour Cycle in Frail Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute on Aging (NIA)

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
To finalize daytime intervention components for a comprehensive sleep-wake intervention for frail older adults and explore feasibility and acceptability using a pilot trial.
Detailed Description
An enhanced intervention addressing both nighttime and daytime activities will be developed based on prior evidence and further informed by data. A successive cohort design will be utilized to evaluate and refine key intervention components and gather feedback on older adults' experiences.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia Disorder
Keywords
sleep-wake patterns, poor sleep

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants enrolled in the pilot trial will receive the intervention, all activities will be unblinded. Older adults utilizing outpatient primary care clinics belonging Atrium Wake Forest Baptist Health. All activities will take place within a clinical setting. Participants will be asked to monitor their sleep-activity behaviors while at home.
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
education and coaching on developing healthy nighttime sleep and daytime activity behaviors
Arm Type
Other
Arm Description
The intervention includes a four-session, in-person program delivered by a Master's-level provider. Each individual session will be approximately 30-45 minutes in length. Each session will include education and coaching on developing healthy nighttime sleep and daytime activity behaviors.
Intervention Type
Behavioral
Intervention Name(s)
education and coaching on developing healthy nighttime sleep and daytime activity behaviors
Intervention Description
The intervention includes a four-session, in-person program delivered by a Master's-level provider. Each individual session will be approximately 30-45 minutes in length. Each session will include education and coaching on developing healthy nighttime sleep and daytime activity behaviors.
Primary Outcome Measure Information:
Title
Sleep efficiency
Description
Total time asleep/total time in bed, per wrist actigraph
Time Frame
Month 2
Secondary Outcome Measure Information:
Title
Insomnia severity scores
Description
Insomnia Severity Index (ISI) is a 7-item validated, self-report questionnaire used to evaluate insomnia severity. Scores range from 0 - 28, higher scores indicate more severe insomnia symptom severity.
Time Frame
Month 2
Title
total daytime activity
Description
Daily activity (total count), per wrist actigraph
Time Frame
Month 2
Title
daytime consequences
Description
per self-reported assessment, daily diary
Time Frame
Month 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 65 or over One or more outpatient primary care visits to Wake Forest Baptist Health in the prior 12 months Meets diagnostic criteria for Insomnia Disorder Less than 30 minutes of daily activity or less than 150 minutes total weekly activity for one month or longer, as reported on brief telephone screener Able to ambulate safely (with or without an assistive device) Able to follow study directions Able to communicate and follow study instructions English speaking Exclusion Criteria: Untreated organic sleep disorder (e.g., central or obstructive sleep apnea, restless leg syndrome) Serious or unstable medical or psychiatric condition that would prevent participation in a behavioral intervention (e.g., terminal illness, uncontrolled psychiatric disorder, substance abuse disorder) Lack of decision-making capacity, as documented in medical record Referred to institutional care and/or currently residing in a nursing home or other residential facility
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bridget A Smeekens
Phone
336.716.5604
Email
AMAZEResearchteam@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime M Hughes, PhD, MPH, MSW
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bridget A Smeekens
Phone
336-716-5604
Email
AMAZEResearchteam@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Jaime M Hughes, PhD, MPH, MSW

12. IPD Sharing Statement

Plan to Share IPD
No

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Sleep Well 24 (SWELL24) Healthy Sleep-Wake Behaviors in Older Adults

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