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

Wake Forest University (WFU)

Status: Completed

Conditions: Insomnia Disorder

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05780983

P30AG021332 (U.S. NIH Grant/Contract)

IRB00089122

Details and patient eligibility

About

To finalize daytime intervention components for a comprehensive sleep-wake intervention for frail older adults and explore feasibility and acceptability using a pilot trial.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 65+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

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

Other group

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.

Treatment:

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