Study of Bedroom Environment Sleep Intervention at Home for Older Adults Living Alone With Memory Concerns

ConditionsSubjective Cognitive Decline (SCD)Mild Cognitive Impairment (MCI)Insomnia

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age65+

SponsorJohns Hopkins University

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Diagnosis of dementia

Presence of acute illness or exacerbation of chronic conditions within the past month.

Current enrollment in another intervention study

Trial design

Design model

Parallel

Treatments tested in this trial

Bedroom Environment Tailoring
Behavioral
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.
Sleep Health Education
Behavioral
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.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Bedroom Environment TailoringExperimental treatment 1 intervention

Group B: Sleep Health EducationActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov

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