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

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05780983
Collaborator
National Institute on Aging (NIA) (NIH)
12
Enrollment
1
Location
1
Arm
13
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: education and coaching on developing healthy nighttime sleep and daytime activity behaviors
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Prevention
Official Title:
Sleep Well 24 (SWELL24): Promoting Healthy Sleep-wake Behaviors Across a 24-hour Cycle in Frail Older Adults
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: education and coaching on developing healthy nighttime sleep and daytime activity behaviors

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.

Behavioral: education and coaching on developing healthy nighttime sleep and daytime activity behaviors
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.

Outcome Measures

Primary Outcome Measures

  1. Sleep efficiency [Month 2]

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

Secondary Outcome Measures

  1. Insomnia severity scores [Month 2]

    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.

  2. total daytime activity [Month 2]

    Daily activity (total count), per wrist actigraph

  3. daytime consequences [Month 2]

    per self-reported assessment, daily diary

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157

Sponsors and Collaborators

  • Wake Forest University Health Sciences
  • National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Jaime M Hughes, PhD, MPH, MSW, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT05780983
Other Study ID Numbers:
  • IRB00089122
  • P30AG021332
First Posted:
Mar 23, 2023
Last Update Posted:
Mar 23, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wake Forest University Health Sciences
sleep-wake patterns
poor sleep
Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Mar 23, 2023