Mild Cognitive ImpairmentNCT05215717
Hypnosis for Sleep Quality for Individuals With Mild Cognitive Impairment
A study testing Self-Administered Hypnosis and Self-Administered White Noise Hypnosis in people with Mild Cognitive Impairment and Poor Quality Sleep, run by Baylor University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Poor Quality Sleep
- What is being tested?
- Self-Administered Hypnosis and Self-Administered White Noise Hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2022to 6 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Self-Administered Hypnosis for Sleep Quality for Individuals With Mild Cognitive Impairment
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.
Read the detailed description
Study Objectives
Aim 1: Determine the accrual, retention, adherence and feasibility, and randomization to the self-administered hypnosis program among individuals with MCI. Feasibility will be determined by (1) drop-out rate, (2) participants' rating of the program, and (3) participants' rating of treatment satisfaction. Adherence will be determined through at-home practice logs. Essential experience on accrual and retention data as well.
Aim 2: Determine feasibility of measures: PSQI, actigraphy recordings, and sleep diaries to assess sleep quality and duration, as well as feasibility of secondary self-report outcome measures of insomnia severity, stress, cognition, and pain among individuals with MCI.
Aim 3: Determine perceptions of hypnosis and potential barriers for the MCI population and feedback.
Participant Selection and Recruitment Plan
A sample of approximately 20 individuals with mild cognitive impairment, both male and female, who suffer from poor sleep will be enrolled in the study. A screening checklist will be used for screening participants who are interested.
Potential participants will be identified (1) via advertisements and press releases, (2) via physician and health care provider referral, support groups (3) and (4) targeted mailings. Participant's eligibility will be determined by criteria listed on a screening checklist. The investigator has used these strategies in prior studies and has demonstrated ability to accrue the required number of participants.
- Conditions
- Mild Cognitive Impairment, Poor Quality Sleep
- Being tested
- Self-Administered Hypnosis, Self-Administered White Noise Hypnosis
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Administered HypnosisBehavioural
Participants randomized to the self-administered hypnosis group will receive five audio-recordings of self-administered hypnosis, specifically targeting sleep improvement, which they will use for daily home practice.
Self-Administered White Noise HypnosisBehavioural
Participants randomized to the white noise hypnosis control will receive the same information and contact with the therapist, but will be provided with audio recordings that contain white noise as a sham hypnosis condition. These recordings include instructions and the use of white noise as a hypnotic induction.
| Study group | Role | What they receive |
|---|---|---|
| Self-Administered Hypnosis | Experimental | Participants randomized to the self-administered hypnosis group will receive five audio-recordings of self-administered hypnosis, specifically targeting sleep improvement, which they will use for daily home practice. Receives: Behavioral: Self-Administered Hypnosis |
| White Noise Hypnosis Control | Active comparator | Participants randomized to the white noise hypnosis control will receive the same information and contact with the therapist but will be provided with audio recordings that contain white noise as a sham hypnosis condition. These recordings include instructions and the use of white noise as a hypnotic induction. Receives: Behavioral: Self-Administered White Noise Hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily At-home Self-Hypnosis Practice Log
All participants will be given guidance on the use of hypnosis and recordings for at-home practice throughout the study. Participants will be instructed in daily practice of hypnosis and asked to keep a daily at-home self-hypnosis practice form during the intervention period. Adherence will be assessed via calculation of participants' frequency of hypnosis practice from these daily hypnosis practice forms. The participant will be asked to practice daily and to complete a practice log, recording the frequency of practice of self-administered hypnosis. Practice logs will be used to assess frequency of practice.
Measured: Through study completion, an average of 7 weeks
Program Rating Scale
In order to assess participants' perceptions of the value of the hypnosis program they receive, they will be asked "How do you rate this hypnosis program overall in regard to ease of use?" and "How do you rate this hypnosis program overall in regard to improving your sleep?" Responses will be given on a 10-point scale ranging from 1 (Poor) to 10 (Excellent) at follow-up.
Measured: One week
Treatment Satisfaction Scale
Participants will be asked to rate their overall level of satisfaction with the intervention. A 10-point VAS scale anchored with 0 "Completely Dissatisfied" to 10 "Completely Satisfied" will be given at follow-up.
Measured: One week
Wrist Actigraphy - Objective Sleep Duration
Wrist actigraphy is a widely used and well-validated measure of sleep duration. Participants will be asked to wear an actigraph (Actiwatch 2; Phillips Respironics, Andover, MA), resembling a wristwatch, on their non-dominant wrist. A motion detection device located within the actigraph records movement. After data is collected and stored within the actigraph it can be analyzed with the Philips Respironics 5 software program.
This program uses a series of logarithms to measure various factors associated with sleep quality, such as total sleep duration, sleep efficiency, sleep onset latency, and the number of times participants woke during the night. Each of these factors will be combined to assess and report objective sleep duration in hours per day/night for participants. For the present study, participants will be asked to wear the actigraph for one week at baseline and for one week at follow-up.
Measured: Up to 2 weeks
Pittsburgh Sleep Quality Index
Participants will be asked to complete the Pittsburgh Sleep Quality Index (PSQI) during screening and at follow-up. The PSQI is a 19-item self-report inventory designed to measure sleep quality. The 19 items are grouped into 7 subscales: 1) sleep quality, 2) sleep efficiency, 3) daytime dysfunction, 4) sleep latency, 5) sleep disturbances, 6) sleep duration, and 7) use of sleep medication. These seven subscales are scored on a scale of 0-3 with higher scores indicating greater sleep pathology. Cronbach's alphas for the PSQI range from .70 to .80.
Measured: Up to 2 weeks
Daily Sleep Diaries
A daily sleep diary where participants record time awake and time to bed will be used. Participants will be asked to complete a daily sleep diary upon awakening each morning for a week at baseline, daily during the intervention weeks, and a week at follow-up.
Measured: Through study completion, an average of 7 weeks
Epworth Sleepiness Scale
Participants will be asked to complete the Epworth Sleepiness Scale (ESS) during baseline and at follow-up. The ESS is an 8-item self-report measure that asks participants to indicate how likely they are to fall asleep while engaging in eight different everyday activities (e.g., watching television, sitting in traffic). Items are scored on a scale from 0-3 with higher scores indicating a greater probability of falling asleep. Previous research indicates that the ESS has a Cronbach's alpha of .88
Measured: Through study completion, an average of 7 weeks
Sleep Environment Questionnaire
Participants will be asked to complete the Sleep Environment Questionnaire during baseline and at follow-up. The Sleep Environment Questionnaire is an 11- item self-report measure that asks about the environment in which a person sleeps. Response options include "True," "False," or "Not Applicable."
Measured: Through study completion, an average of 7 weeks
Attitudes Toward Hypnosis Scale
The 14-item Attitudes Toward Hypnosis Scale will be used to assess attitudes toward hypnosis at baseline and at follow-up. This scale has shown internal consistency in previous studies, Cronbach's alpha = .81. A total attitude toward hypnosis score will be calculated for each participant by summing scores across the 14 items with higher scores indicating more positive attitudes toward hypnosis.
Measured: Through study completion, an average of 7 weeks
Secondary outcomes (5)
Insomnia Severity Index
Participants will be asked to complete the Insomnia Severity Index (ISS) at baseline and follow-up. The ISI consists of seven items that measure the severity of sleep onset, sleep maintenance, and early morning awakening problems, as well as the participant's satisfaction with her current sleep pattern, the extent to which lack of sleep interferes with daily functioning, how noticeable this impairment is to other people, and the extent to which the participant is worried or distressed about their lack of sleep. Items are scored on a scale from 0-4 with total score of 15 or higher indicating the presence of clinical insomnia24. Past research indicates that internal reliability estimates for the ISI range from .74 to .78.
Measured: Through study completion, an average of 7 weeks
Perceived Stress Scale
The Perceived Stress Scale (PSS) will be used to measure stress at baseline and follow-up. The PSS includes 14 items that assess levels of perceived stress and to what degree individuals perceive events in their life as stressful during the previous month. Higher scores indicate greater stress. Past research indicates that Cronbach's alpha for the PSS is .85.
Measured: Through study completion, an average of 7 weeks
PROMIS Cognitive Function - Short Form
Cognition will be assessed at baseline and at follow-up using the PROMIS Cognitive Function - Short Form Scale. This scale includes 8 items and measures self-reported cognitive functioning during the past 7 days. Items are scored from a scale of 1 (Very Often) to 5 (Never). Items are summed to create a total score and higher scores indicate better cognitive functioning.
Measured: Through study completion, an average of 7 weeks
Pain Visual Analog Scale
Participants will be asked to rate their pain on a 100-mm visual analog scale (VAS) during baseline and follow-up. Participants will be asked to place an "x" along the 100-mm line to indicate the severity of their pain over the past week, with the lower end of the scale being anchored by the phrase "no pain" and the upper end of the scale being anchored by the phrase "the most intense pain possible."
Measured: Through study completion, an average of 7 weeks
Motivation Scale
Motivation to use hypnosis is an important factor to be assessed. Motivation to use hypnosis to improve sleep quality will be assessed at baseline using a numerical rating scale that states, "How motivated are you to use hypnosis to improve sleep?" This item will be rated on a scale of 1 (Not Motivated at All) to 10 (Very Motivated).
Measured: One week during baseline week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start22 Feb 2022
- Primary completion6 Nov 2022
- Study completion6 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized and enrolled into one of two study groups, self-administered hypnosis (treatment group) or sham white noise hypnosis (control group).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Gary R. Elkins, Baylor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215717
- Sponsor's protocol ID
- 3R01AT009384-05S1
- Status last verified
- Mar 2024
- First submitted
- 3 Jan 2022
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Self-Administered Hypnosis for Sleep Quality for Individuals With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05215717
- Acronym / sponsor ID
- 3R01AT009384-05S1
- Conditions
- Mild Cognitive Impairment, Poor Quality Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 6 Nov 2022 (actual)
- Study completion
- 6 Nov 2022 (actual)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Objectives
Aim 1: Determine the accrual, retention, adherence and feasibility, and randomization to the self-administered hypnosis program among individuals with MCI. Feasibility will be determined by (1) drop-out rate, (2) participants' rating of the program, and (3) participants' rating of treatment satisfaction. Adherence will be determined through at-home practice logs. Essential experience on accrual and retention data as well.
Aim 2: Determine feasibility of measures: PSQI, actigraphy recordings, and sleep diaries to assess sleep quality and duration, as well as feasibility of secondary self-report outcome measures of insomnia severity, stress, cognition, and pain among individuals with MCI.
Aim 3: Determine perceptions of hypnosis and potential barriers for the MCI population and feedback.
Participant Selection and Recruitment Plan
A sample of approximately 20 individuals with mild cognitive impairment, both male and female, who suffer from poor sleep will be enrolled in the study. A screening checklist will be used for screening participants who are interested.
Potential participants will be identified (1) via advertisements and press releases, (2) via physician and health care provider referral, support groups (3) and (4) targeted mailings. Participant's eligibility will be determined by criteria listed on a screening checklist. The investigator has used these strategies in prior studies and has demonstrated ability to accrue the required number of participants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized and enrolled into one of two study groups, self-administered hypnosis (treatment group) or sham white noise hypnosis (control group).
| Arm | Type | Receives |
|---|---|---|
| Self-Administered Hypnosis | Experimental | Behavioral: Self-Administered HypnosisParticipants randomized to the self-administered hypnosis group will receive five audio-recordings of self-administered hypnosis, specifically targeting sleep improvement, which they will use for daily home practice. |
| White Noise Hypnosis Control | Active comparator | Behavioral: Self-Administered White Noise HypnosisParticipants randomized to the white noise hypnosis control will receive the same information and contact with the therapist but will be provided with audio recordings that contain white noise as a sham hypnosis condition. These recordings include instructions and the use of white noise as a hypnotic induction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Administered HypnosisParticipants randomized to the self-administered hypnosis group will receive five audio-recordings of self-administered hypnosis, specifically targeting sleep improvement, which they will use for daily home practice. | Behavioural | Self-Administered Hypnosis |
| Self-Administered White Noise HypnosisParticipants randomized to the white noise hypnosis control will receive the same information and contact with the therapist, but will be provided with audio recordings that contain white noise as a sham hypnosis condition. These recordings include instructions and the use of white noise as a hypnotic induction. | Behavioural | White Noise Hypnosis Control |
Primary outcome
Daily At-home Self-Hypnosis Practice Log
Time frame: Through study completion, an average of 7 weeks
All participants will be given guidance on the use of hypnosis and recordings for at-home practice throughout the study. Participants will be instructed in daily practice of hypnosis and asked to keep a daily at-home self-hypnosis practice form during the intervention period. Adherence will be assessed via calculation of participants' frequency of hypnosis practice from these daily hypnosis practice forms. The participant will be asked to practice daily and to complete a practice log, recording the frequency of practice of self-administered hypnosis. Practice logs will be used to assess frequency of practice.
Program Rating Scale
Time frame: One week
In order to assess participants' perceptions of the value of the hypnosis program they receive, they will be asked "How do you rate this hypnosis program overall in regard to ease of use?" and "How do you rate this hypnosis program overall in regard to improving your sleep?" Responses will be given on a 10-point scale ranging from 1 (Poor) to 10 (Excellent) at follow-up.
Treatment Satisfaction Scale
Time frame: One week
Participants will be asked to rate their overall level of satisfaction with the intervention. A 10-point VAS scale anchored with 0 "Completely Dissatisfied" to 10 "Completely Satisfied" will be given at follow-up.
Wrist Actigraphy - Objective Sleep Duration
Time frame: Up to 2 weeks
Wrist actigraphy is a widely used and well-validated measure of sleep duration. Participants will be asked to wear an actigraph (Actiwatch 2; Phillips Respironics, Andover, MA), resembling a wristwatch, on their non-dominant wrist. A motion detection device located within the actigraph records movement. After data is collected and stored within the actigraph it can be analyzed with the Philips Respironics 5 software program. This program uses a series of logarithms to measure various factors associated with sleep quality, such as total sleep duration, sleep efficiency, sleep onset latency, and the number of times participants woke during the night. Each of these factors will be combined to assess and report objective sleep duration in hours per day/night for participants. For the present study, participants will be asked to wear the actigraph for one week at baseline and for one week at follow-up.
Pittsburgh Sleep Quality Index
Time frame: Up to 2 weeks
Participants will be asked to complete the Pittsburgh Sleep Quality Index (PSQI) during screening and at follow-up. The PSQI is a 19-item self-report inventory designed to measure sleep quality. The 19 items are grouped into 7 subscales: 1) sleep quality, 2) sleep efficiency, 3) daytime dysfunction, 4) sleep latency, 5) sleep disturbances, 6) sleep duration, and 7) use of sleep medication. These seven subscales are scored on a scale of 0-3 with higher scores indicating greater sleep pathology. Cronbach's alphas for the PSQI range from .70 to .80.
Daily Sleep Diaries
Time frame: Through study completion, an average of 7 weeks
A daily sleep diary where participants record time awake and time to bed will be used. Participants will be asked to complete a daily sleep diary upon awakening each morning for a week at baseline, daily during the intervention weeks, and a week at follow-up.
Epworth Sleepiness Scale
Time frame: Through study completion, an average of 7 weeks
Participants will be asked to complete the Epworth Sleepiness Scale (ESS) during baseline and at follow-up. The ESS is an 8-item self-report measure that asks participants to indicate how likely they are to fall asleep while engaging in eight different everyday activities (e.g., watching television, sitting in traffic). Items are scored on a scale from 0-3 with higher scores indicating a greater probability of falling asleep. Previous research indicates that the ESS has a Cronbach's alpha of .88
Sleep Environment Questionnaire
Time frame: Through study completion, an average of 7 weeks
Participants will be asked to complete the Sleep Environment Questionnaire during baseline and at follow-up. The Sleep Environment Questionnaire is an 11- item self-report measure that asks about the environment in which a person sleeps. Response options include "True," "False," or "Not Applicable."
Attitudes Toward Hypnosis Scale
Time frame: Through study completion, an average of 7 weeks
The 14-item Attitudes Toward Hypnosis Scale will be used to assess attitudes toward hypnosis at baseline and at follow-up. This scale has shown internal consistency in previous studies, Cronbach's alpha = .81. A total attitude toward hypnosis score will be calculated for each participant by summing scores across the 14 items with higher scores indicating more positive attitudes toward hypnosis.
5 secondary outcomes
Insomnia Severity Index
Time frame: Through study completion, an average of 7 weeks
Perceived Stress Scale
Time frame: Through study completion, an average of 7 weeks
PROMIS Cognitive Function - Short Form
Time frame: Through study completion, an average of 7 weeks
Pain Visual Analog Scale
Time frame: Through study completion, an average of 7 weeks
Motivation Scale
Time frame: One week during baseline week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Administered Hypnosis and Self-Administered White Noise Hypnosis in people with Mild Cognitive Impairment and Poor Quality Sleep, run by Baylor University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily At-home Self-Hypnosis Practice Log (time frame: Through study completion, an average of 7 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.