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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05780983
Other study ID # IRB00089122
Secondary ID P30AG021332
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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