Insomnia, Mild Cognitive Impairment (MCI), Subjective Cognitive Decline (SCD)
Conditions
Keywords
insomnia, home-based intervention, randomized controlled trial, environmental sensors, community-dwelling older adults, sleep
Brief summary
This is an eight-week pilot research study designed to test whether simple changes to the bedroom environment along with brief sleep hygiene strategies, can improve sleep in older adults who live alone, have memory concerns, and experience insomnia symptoms. Older adults may be eligible to participate. The intervention will take 8 weeks, which includes 1-2 in-person visits from the research team at the participant's residence (evaluate the bedroom environment, install participant-agreed bedroom changes, deliver target sleep hygiene strategy) and 2 virtual or telephone calls (support environmental and sleep hygiene strategies) over 8 weeks. Sleep and environment data will be collected at screening/baseline, mid-intervention (4-week) and post-intervention (8-week)
Interventions
BEHAVIORALBedroom Environment Tailoring
Within two weeks of completing the parent study and consent, participants begin the personalized bedroom sleep environment program. During in one or two in-home visits, a research team member will review baseline sensor and actigraphy data and install low-cost environmental modifications (e.g., blackout shades, white-noise device, air purifier, thermostat adjustments). Participants collaborate with the coach to set stimulus-control goals and receive individualized sleep-hygiene guidance. A 30-45-minute virtual follow-up in Weeks 2-3 reviews progress and addresses barriers, with a brief Week 6 check-in to reinforce goals. Ongoing support includes daily self-practice, optional between-visit contact, automated reminders, and passive sensor monitoring to promote adherence and confidence in managing sleep.
BEHAVIORALSleep Health Education
The control group receives a single in-person or virtual session that provides participants with printed and online sleep health education materials. This introductory session aims to equip participants with foundational knowledge about sleep hygiene. Following this initial session, participants will engage in eight weeks of self-directed practice, allowing the participant to apply the information learned at the participant's own pace.
Sponsors
Johns Hopkins University
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 65 years and older * Living alone in a private residence or independent living setting ≥5 days/week * Subjective cognitive decline (Subjective Cognitive Decline Questionnaire MyCog \> 7\] OR objective mild cognitive impairment (Montreal Cognitive Assessment \[MoCA\] scores between 18-25). * Preserved Function (Functional Activity Questionnaire \< 6) * Community-dwelling * Self-reported insomnia symptoms * Residence in the current home for ≥3 months * Expectation to sleep in the designated bedroom on ≥80% of nights during the 8 week protocol
Exclusion criteria
* Diagnosis of dementia * Presence of acute illness or exacerbation of chronic conditions within the past month. * Current enrollment in another intervention study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of study and intervention | Duration of study, approximately 2 years | Feasibility will be assessed by recruitment, retention, fidelity, and safety over the study period, with progression thresholds: ≥70% eligible enrollee ≥85% retained to Week 8, treatment fidelity (coaching delivered ≥80%), and no serious intervention-related adverse events. |
| Subjective sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) | Baseline, 4-weeks, 8-weeks | Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report measure of overall sleep quality and disturbances over the past 30 days. It includes seven component scores-subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction-each scored 0-3 (0 = no difficulty; 3 = severe difficulty). Component scores are summed to a global score (0-21), with higher scores indicating worse sleep quality; the global score will be used in the analysis |
Contacts
CONTACTJUNXIN LI
CONTACTYoungmin Cho
PRINCIPAL_INVESTIGATORJunxin Li, PhD, RN
Johns Hopkins University School of Nursing
Outcome results
None listed