Recruiting

Sleep Enhancement

Sponsor:

Emory University

Code:

NCT06250725

Conditions

Sleep Disturbance

Dementia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Cognitive Behavioral Therapy for Insomnia

Study Details

Brief summary:

The purpose of this study is to determine if a 6-week videoconference intervention to teach skills to improve sleep is practical, acceptable, and helpful to persons living with memory loss, cognitive impairment, and/or dementia and care partners, individually or together.

Conditions

Sleep Disturbance

Dementia

Study ID

NCT06250725

Start date

Aug 1, 2024

Status verified date

Feb, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria for the PLwCI:

  • Diagnosis of Alzheimer's Disease and Related Dementias (ADRD), or caregiver-reported probable or possible cognitive impairment or
  • Montreal Cognitive Assessment (MOCA) score between 12 and 24;
  • Had ≥1 sleep problem ≥3x/week on the Neuropsychiatric Inventory (NPI)-Nighttime Behavior Subscale;
  • Have an eligible caregiver;
  • Be able to participate in the intervention sessions

Inclusion Criteria for Caregivers:

  • ≥18 years old, co-residing with persons living with cognitive impairment (PLwCI);
  • Regularly assist the care recipient with ≥1 of 7 basic activities of daily living or
  • ≥1 of 7 Instrumental Activities of Daily Living for the past 6 months;
  • Have difficulty falling asleep or difficulty staying asleep for the last three months or
  • Have a Pittsburgh Sleep Quality Index (PSQI) of 5 or greater

Exclusion Criteria:

  • PLwCI: Moderate to severe cognitive impairment
  • Individuals who are not yet adults
  • Pregnant women
  • Prisoners
  • Individuals who are not able to clearly understand English.

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Cognitive Behavioral Therapy for Insomnia (CBTi)

Participant dyads will receive CBTi via videoconferencing sessions

Interventions

Cognitive Behavioral Therapy for Insomnia

The intervention protocol will include CBTi principles like stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring. It will be done over 6 weeks with one session weekly via videoconference.

Primary outcome measure

  • Change in insomnia [ Time Frame: Baseline, 1-week post-intervention, and 3 months post-intervention ]
  • Change in Sleep Efficiency [ Time Frame: Baseline, 1-week post-intervention, and 3 months post-intervention ]
  • Change in in Sleep Onset Latency [ Time Frame: Baseline, 1-week post-intervention, and 3 months post-intervention ]
  • Change in Wake After Sleep Onset [ Time Frame: Baseline, 1-week post-intervention, and 3 months post-intervention ]
  • Adherence with Study Interventions (feasibility) [ Time Frame: weekly during the intervention period up to 3 months post-intervention ]
  • Satisfaction with intervention components [ Time Frame: 1 week post-intervention ]

Central Contacts and Locations

Central contacts

Glenna S Brewster, PhD, RN, FNP

(404) 712-9164glenna.brewster@emory.edu

Locations

Emory Healthcare System

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Rashidat Ayantunji

404-727-9953rayantu@emory.edu

More Information

Sponsor

Emory University

Last update posted

Mar 3, 2026

Last verified

Feb, 2026

Keywords

  • Persons living with dementia (PLwD)
  • Caregivers
  • Cognitive Behavioral Therapy for Insomnia (CBTi)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-03-03.