Trial Outcomes & Findings for Sleep Well 24 (SWELL24) Healthy Sleep-Wake Behaviors in Older Adults (NCT NCT05780983)

NCT ID: NCT05780983

Last Updated: 2025-10-30

Results Overview

Total number of minutes asleep divided by total time in bed measure by wrist actigraph

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 7 participants
• Primary outcome timeframe: Month 2
• Results posted on: 2025-10-30

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	7
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	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.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Education and Coaching on Developing Healthy Nighttime Sleep and Daytime Activity Behaviors n=7 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Education	14.9 years n=5 Participants

PRIMARY outcome

Timeframe: Month 2

Total number of minutes asleep divided by total time in bed measure by wrist actigraph

Outcome measures

Measure	Education and Coaching on Developing Healthy Nighttime Sleep and Daytime Activity Behaviors n=6 Participants 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.
Sleep Efficiency	95.1 percent Standard Deviation 1.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Education and Coaching on Developing Healthy Nighttime Sleep and Daytime Activity Behaviors n=6 Participants 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.
Insomnia Severity Scores	9.67 score on a scale Standard Deviation 9.7

SECONDARY outcome

Timeframe: Month 2

Daily activity (total count of steps), per wrist actigraph

Outcome measures

Measure	Education and Coaching on Developing Healthy Nighttime Sleep and Daytime Activity Behaviors n=6 Participants 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.
Total Daytime Activity	5188 steps Standard Deviation 2475

SECONDARY outcome

Timeframe: Month 2

Pittsburgh Sleep Quality Index: Daily Disturbances score using the 3-factor scoring model, per self-reported assessment. Scores range from 0-6. Higher scores indicate more daily disturbance.

Outcome measures

Measure	Education and Coaching on Developing Healthy Nighttime Sleep and Daytime Activity Behaviors n=6 Participants 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.
Pittsburgh Sleep Quality Index Score	1.2 score on a scale Standard Deviation 0.4

Adverse Events

Education and Coaching on Developing Healthy Nighttime Sleep and Daytime Activity Behaviors

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jaime M Hughes, PhD, MPH, MSW

Wake Forest University Health Sciences

Phone: 336-716 -0835

Email: jane.hughes@wfusm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place