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Not yet recruiting NCT07440498

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

No phase Interventional Subjective Cognitive Decline (SCD) Mild Cognitive Impairment (MCI) Insomnia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bedroom Environment Tailoring, Sleep Health Education.
Who it may be relevant to
Registry conditions: Subjective Cognitive Decline (SCD), Mild Cognitive Impairment (MCI), Insomnia. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Behavioral Bedroom 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
  • Behavioral Sleep 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.

Primary outcome measures

  • Feasibility of study and intervention [Time frame: Duration of study, approximately 2 years]
  • Subjective sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline, 4-weeks, 8-weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07440498 · IRB00543636

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗