Sleep Health Education for Insomnia

(SWELL24 Trial)

Overseen By Laura Welti

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Sleep apnea, Terminal illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

7 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Jaime M Hughes, PhD, MPH, MSW

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

The SWELL24 trial is for adults over 65 who have insomnia, can follow instructions, and have had a primary care visit at Wake Forest Baptist Health in the past year. They should be physically inactive but able to walk safely with or without help. Those with serious medical conditions, untreated sleep disorders like sleep apnea or restless leg syndrome, substance abuse issues, or living in institutional care cannot join.

Inclusion Criteria

English speaking

I can walk safely on my own or with help.

I am 65 years old or older.

Exclusion Criteria

I have not been treated for any sleep disorders like sleep apnea or restless leg syndrome.

My medical records show I cannot make my own health decisions.

Referred to institutional care and/or currently residing in a nursing home or other residential facility

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive education and coaching on developing healthy nighttime sleep and daytime activity behaviors through a four-session, in-person program

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for sleep efficiency and insomnia severity using wrist actigraph and self-reported assessments

4 weeks

Treatment Details

Interventions

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

Trial Overview This study tests an intervention that includes education and coaching to promote healthy sleep-wake behaviors among older adults. It aims to establish effective daytime activities as part of a comprehensive approach to improve their overall sleep quality.

Participant Groups

Group I: education and coaching on developing healthy nighttime sleep and daytime activity behaviors Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+