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

NCT07440498 | Not Yet Recruiting

• 1 other identifier: IRB00543636
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Subjective Cognitive Decline (SCD); Mild Cognitive Impairment (MCI); Insomnia

Keywords

insomnia; home-based intervention; randomized controlled trial; environmental sensors; community-dwelling older adults; sleep

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Baseline, 4-weeks, 8-weeks

Study Arms (2)

Bedroom Environment Tailoring

EXPERIMENTAL

Behavioral: Bedroom Environment Tailoring

Sleep Health Education

ACTIVE COMPARATOR

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

Interventions

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.

Bedroom Environment Tailoring

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.

Sleep Health Education

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of dementia
• Presence of acute illness or exacerbation of chronic conditions within the past month.
• Current enrollment in another intervention study

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Aging (NIA): collaborator

MeSH Terms

Conditions

Cognitive Dysfunction; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Junxin Li, PhD, RN

  Johns Hopkins University School of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JUNXIN LI

CONTACT

4105022608; jli248@jhu.edu

Youngmin Cho

CONTACT

ycho68@jh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-06