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NCT Number: NCT07440498

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

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)

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Key information

Conditions

Subjective Cognitive Decline (SCD) Cognition Disorders Cognitive Dysfunction Dyssomnias Insomnia Mental Disorders Mild Cognitive Impairment (MCI) Nervous System Diseases Neurocognitive Disorders Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of study and intervention

    Time frame: 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.

  2. Subjective sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

JUNXIN LI

CONTACT

[email protected]

4105022608

Youngmin Cho

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 27, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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