InsomniaNCT04242771
Mindfulness Meditation for Insomnia
A study testing Mindfulness in people with Insomnia, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This is a pilot study evaluating the feasibility and acceptability of a non-pharmacological, mind-body intervention to improve sleep quality, including a preliminary evaluation of neurophysiological signals. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2022to 1 Aug 2023
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. age 20 - 50 years*
- 2. chronic insomnia (defined by Diagnostic and Statistical Manual Diploma in Social Medicine, DSM-V or International Classification of Sleep Disorders - Third Edition, ICSD-3) with sleep latency >20 minutes
- 3. speak and understand English
- 4. have a smart phone for mobile app installation
Who cannot join
- 1. sleep disorders other than insomnia (e.g., narcolepsy, restless leg syndrome, sleep deprivation, jet lag, etc)
- 2. shift worker or routine night shifts
- 3. women with pregnancy or breast feeding
- 4. history of head trauma or surgery
- 5. regular (defined as twice a week or more) practice of mind-body interventions
- 6. neurological disorders (e.g. epilepsy, dementia, stroke, Parkinson's disease, neuroinfections, brain tumors, etc.)
- 7. current use of neurologic, psychiatric, or cardiovascular medications that have expected neuropsychiatric or cardiovascular effects (i.e., beta-blockers, hypnotics, antidepressants).
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Neurophysiological Patterns of Mindfulness Meditation for Insomnia
This is a pilot study evaluating the feasibility and acceptability of a non-pharmacological, mind-body intervention to improve sleep quality, including a preliminary evaluation of neurophysiological signals. The study involves 4 weeks of guided mind-body practice at home using a smartphone app during bedtime and pre/post in-lab sleep study visits.
- Conditions
- Insomnia
- Being tested
- Mindfulness
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
Subjects practice mindfulness before bedtime
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants will utilize a daily sleep program available within a widely used smartphone app, which includes seven soundtracks (10-15min each) for guided mindfulness practice at bedtime. Techniques include breathing exercises, mental imagery, awareness of body and mind, and muscle and body relaxation. Receives: Behavioral: Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (i.e., subject retention at initial follow-up assessment)
The primary metric for assessing Feasibility will be subject retention at the initial follow-up assessment. This includes the proportion of enrolled subjects that are active in the study at the initial follow-up assessment.
Measured: At one month follow up visit
Secondary outcomes (1)
Acceptability
The primary metric for assessing Acceptability will be a self-report Acceptability questionnaire which evaluates enjoyableness, convenience, helpfulness, relevancy, odds of future use, and overall satisfaction of the program.
Measured: At completion of the 4 week program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start2 Dec 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gloria Y. Yeh, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242771
- Sponsor's protocol ID
- 2019P000984
- Status last verified
- Mar 2024
- First submitted
- 23 Jan 2020
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Patterns of Mindfulness Meditation for Insomnia
- ClinicalTrials.gov ID
- NCT04242771
- Acronym / sponsor ID
- 2019P000984
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 27 Jan 2020 (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.
This is a pilot study evaluating the feasibility and acceptability of a non-pharmacological, mind-body intervention to improve sleep quality, including a preliminary evaluation of neurophysiological signals. The study involves 4 weeks of guided mind-body practice at home using a smartphone app during bedtime and pre/post in-lab sleep study visits.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: MindfulnessParticipants will utilize a daily sleep program available within a widely used smartphone app, which includes seven soundtracks (10-15min each) for guided mindfulness practice at bedtime. Techniques include breathing exercises, mental imagery, awareness of body and mind, and muscle and body relaxation. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1. age 20 - 50 years*
- 2. chronic insomnia (defined by Diagnostic and Statistical Manual Diploma in Social Medicine, DSM-V or International Classification of Sleep Disorders - Third Edition, ICSD-3) with sleep latency >20 minutes
- 3. speak and understand English
- 4. have a smart phone for mobile app installation
Key exclusion criteria (7 listed)
- 1. sleep disorders other than insomnia (e.g., narcolepsy, restless leg syndrome, sleep deprivation, jet lag, etc)
- 2. shift worker or routine night shifts
- 3. women with pregnancy or breast feeding
- 4. history of head trauma or surgery
- 5. regular (defined as twice a week or more) practice of mind-body interventions
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 |
|---|---|---|
| MindfulnessSubjects practice mindfulness before bedtime | Behavioural | Experimental group |
Primary outcome
Feasibility (i.e., subject retention at initial follow-up assessment)
Time frame: At one month follow up visit
The primary metric for assessing Feasibility will be subject retention at the initial follow-up assessment. This includes the proportion of enrolled subjects that are active in the study at the initial follow-up assessment.
1 secondary outcome
Acceptability
Time frame: At completion of the 4 week program
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 18 Mar 2024.
- Individual participant dataSharing planned: No
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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 Mindfulness in people with Insomnia, run by Beth Israel Deaconess Medical Center 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 4 inclusion and 7 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 18 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?
Feasibility (i.e., subject retention at initial follow-up assessment) (time frame: At one month follow up visit). 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 18 Mar 2024.