An interventional study of Bedroom Environment Tailoring and Sleep Health Education in Subjective Cognitive Decline (SCD), Mild Cognitive Impairment (MCI) and Insomnia, sponsored by Johns Hopkins University. Not yet recruiting. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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)
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's planned enrollment of 40 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
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Exclusion Criteria:
Behavioral: Bedroom Environment Tailoring
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 participants to apply the information learned at the participant's own pace.
Behavioral: Sleep Health Education
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.
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.
Feasibility of study and intervention
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.
Time frame: Duration of study, approximately 2 years
Subjective sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
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
Time frame: Baseline, 4-weeks, 8-weeks
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Johns Hopkins University