Clinical trial for Insomnia
Official title Deep Sleep in Older Adults
ClinicalTrials.gov ID: NCT07316153
What this study is testing
- What it's testing
- This study is testing whether adding internet‑connected devices and artificial intelligence to CBT‑I improves sleep in older people.
- Who it's for
- You may be able to join if you are an older adult who lives independently and has trouble sleeping.
- What's involved
- You will use a sleep app, wear a sleep tracker, and answer short surveys. You may also do brief thinking tests.
- Time commitment
- The study lasts several weeks with weekly check‑ins and continuous device wear.
- Phase 2: a mid-size study of how well it works
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older
You may be able to join if
- Fluent English speaker and reader.
- Capable of providing one's own informed consent.
- As determined by validated, abbreviated phone-based remote Montreal Cognitive Assessment (MoCA) testing score of ≥18, which is the score that...
- Age 55+ years old (inclusive) at enrollment. a. As self-reported on screening survey and later verified in video appointment (e.g. Zoom Health)
- If residing in a community residence (such as a retirement community) in which a Medical Director designates living status categories, then the...
You likely can't join if
- Illicit drug use in the past month (except for marijuana because it is legal in many States, and the investigators are recruiting nationwide). a.
- Diagnosed serious mental health disorder.
- Specifically, psychosis or bipolar depression, severe major depression, moderate to high risk of suicide, dementia
- As self-reported on screening survey
- Currently or recent engaged (past 1-year) in evidence-based psychotherapy for Insomnia (e.g., CBTi), in addition to ever receiving a full course of...
- Cohabitating with a current or previous participant in this study. a.
See the full eligibility criteria
- Fluent English speaker and reader.
- Capable of providing one's own informed consent.
- As determined by validated, abbreviated phone-based remote Montreal Cognitive Assessment (MoCA) testing score of ≥18, which is the score that separates Mild Cognitive Impairment (MCI) from Alzheimer's Disease and...
- Age 55+ years old (inclusive) at enrollment. a. As self-reported on screening survey and later verified in video appointment (e.g. Zoom Health)
- If residing in a community residence (such as a retirement community) in which a Medical Director designates living status categories, then the participant must be Independent Living status (or equivalent).
- As self-reported on screening survey
- Insomnia Severity Index score ≥15 (i.e., at least "clinical insomnia," that is "moderate-to-severe") - but if recruitment is slow then the investigators will recruit with ISI score ≥11 "mild-to-severe"). a.
- Willing to refrain from initiating new therapeutic interventions (e.g. medication; behavioral) that are not a part of this study protocol for issues pertaining to sleep for the duration of study participation. a.
- Willing to maintain any existing physician-directed pharmacologic intervention for issues pertaining to sleep for the duration of study participation. a. By self-report
- Has a residence with WIFI. a. By self-report
- Normal hearing with or without a hearing aid. a. By self-report
- Difficulty falling asleep, staying asleep, or waking too early, occurring at least 3 nights/week for 3+months, causing significant daytime distress/impairment (e.g., fatigue, poor focus, mood issues), despite adequate...
- By Sleep Condition Indicator [SCI]
- Illicit drug use in the past month (except for marijuana because it is legal in many States, and the investigators are recruiting nationwide). a. As self-reported on screening survey.
- Diagnosed serious mental health disorder.
- Specifically, psychosis or bipolar depression, severe major depression, moderate to high risk of suicide, dementia
- As self-reported on screening survey
- Currently or recent engaged (past 1-year) in evidence-based psychotherapy for Insomnia (e.g., CBTi), in addition to ever receiving a full course of CBTi: a. By self-report
- Cohabitating with a current or previous participant in this study. a. This criterion is to avoid cross-contamination of study condition awareness, if two cohabitating individuals are assigned by chance into different...
- Initiation of any psychological treatment in the last 3-months.
- A highly irregular schedule (e.g. shift work) that would prevent adoption of intervention strategies, as evaluated through the Shift Work Disorder Index.
- Previous exposure to the SleepSpace software.
- Medical conditions that are exacerbated by sleep restriction.
- Planned major surgery during the trial.
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.