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

Insomnia Disorder Clinical Trial

— SWELL24  

Official title:

Sleep Well 24 (SWELL24): Promoting Healthy Sleep-wake Behaviors Across a 24-hour Cycle in Frail Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05780983
• Other study ID #: IRB00089122
• Secondary ID: P30AG021332
• Status: Recruiting
• Phase: N/A
• Start date: May 8, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2024
• Source: Wake Forest University Health Sciences
• Contact: Laura Welti
• Phone: 336.716.5604
• Email: AMAZEResearchteam[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insomnia Disorder
• Sleep Initiation and Maintenance Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep efficiency	Total time asleep/total time in bed, per wrist actigraph	Month 2
Secondary	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.	Month 2
Secondary	total daytime activity	Daily activity (total count), per wrist actigraph	Month 2
Secondary	daytime consequences	per self-reported assessment, daily diary	Month 2