Hypnosis for Sleep Quality for Individuals With Mild Cognitive Impairment (NCT05215717) | Clinical Trial Compass
CompletedNot Applicable
Hypnosis for Sleep Quality for Individuals With Mild Cognitive Impairment
United States23 participantsStarted 2022-02-22
Plain-language summary
With the long-range goal to identify an efficacious and practical intervention to improve sleep for individuals with MCI, this pilot study will enroll 20 individuals with MCI into either a self-administered hypnosis for sleep program or a sham white noise hypnosis program. Participants will practice hypnosis delivered via audio recording once per day in their own home for 7 weeks. Upon completion of the study, insight will be gained regarding accrual, retention, and feasibility of the intervention and measures. Data from this pilot study is essential to inform and plan a future R01 proposal to determine the efficacy of the self-administered hypnosis intervention to improve sleep quality and duration, as well as other benefits, with individuals with mild cognitive impairment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Self-report of MCI (a score of less than or equal to 3 on the Memory Complaint Scale30) and a score between 7-18 on the Montreal Cognitive Assessment (MoCA) - BLIND Version 8.121
* Self-reported sleep duration of less than or equal to 6 hours per day/night as indicated on the PSQI
* Signed informed consent
Exclusion Criteria:
* Use of any prescription or over-the-counter therapy for sleep
* Severe or unstable medical or psychiatric illness
* Current use of hypnosis for any condition
* Inability to speak or understand English
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Daily At-home Self-Hypnosis Practice Log
Timeframe: Through study completion, an average of 7 weeks
2
Program Rating Scale
Timeframe: One week
3
Treatment Satisfaction Scale
Timeframe: One week
4
Wrist Actigraphy - Objective Sleep Duration
Timeframe: Up to 2 weeks
5
Pittsburgh Sleep Quality Index
Timeframe: Up to 2 weeks
6
Daily Sleep Diaries
Timeframe: Through study completion, an average of 7 weeks
7
Epworth Sleepiness Scale
Timeframe: Through study completion, an average of 7 weeks