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| Name | Class |
|---|---|
| Center for Advancing Point of Care Technologies | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The goal of this research is to assess the utility of smartphone-based progressive muscle relaxation (PMR) for the treatment of migraine and sleep. While there are many commercially available electronic diary and mind-body intervention apps for headache, there is little data showing their efficacy. RELAXaHEAD app incorporates the electronic PMR that was successfully used in an earlier epilepsy study and beta tested with headache specialist and migraine patient input. It also is an electric headache diary. The app has been studied and findings have been reported in multiple peer reviewed publications. Also, the app has been updated based on prior feedback from the studies. Now, this 2-arm randomized controlled study will evaluate the feasibility and acceptability of RELAXaHEAD for use with patients with migraine and comorbid insomnia. . One arm will be the RELAX group (the RELAXaHEAD app) and the other arm will be a monitored usual care (MUC) group (this group receives standard of care and uses the electronic daily symptom reporting diary). The goals are to assess the feasibility and adherence of the RELAX intervention in persons with migraine and insomnia (Aim 1) and to gather exploratory data on the effects of the RELAX intervention on headache and sleep related outcome measures (Aim 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RELAX | Experimental | Patients will receive Progressive Muscle Relaxation Therapy (PMR) via the RELAXaHEAD smart-phone app. Patients will be asked to do the following:
Patients will be asked to track headache frequency, intensity, sleep, and acute medication use on the app. They will also receive written educational material about migraine. |
|
| Monitored Usual Care (MUC) | Active Comparator | Patients will be given a general education session consisting of basic migraine information. They will receive the RELAXaHEAD app but the Progressive Muscle Relaxation Therapy (PMR) function will be blocked. Patients will be asked to track headache frequency, intensity, sleep, and acute medication use on the RELAXaHEAD app. They will also receive written educational material about migraine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartphone-Based Progressive Muscle Relaxation Therapy (PMR) | Behavioral | Relaxation technique delivered via RELAXaHEAD app. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Enrolled in the Study | Measure of feasibility. | Baseline |
| Daily Diary Satisfaction Scores | 5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction. | Baseline |
| Daily Diary Satisfaction Scores | 5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction. | Week 1 |
| Daily Diary Satisfaction Scores | 5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction. | Month 1 |
| Daily Diary Satisfaction Scores | 5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mia Minen, MD | NYU Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41206664 | Derived | Minen MT, George A, Bostic R, Fanning K, Bubu OM. The association between insomnia and migraine disability and quality of life: a secondary analysis of a randomized controlled trial. Pain Med. 2026 Apr 1;27(4):426-433. doi: 10.1093/pm/pnaf149. |
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The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to Dr. Minen (PI). The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to alexis.george@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | RELAX | Patients will receive Progressive Muscle Relaxation Therapy (PMR) via the RELAXaHEAD smart-phone app. Patients will be asked to do the following:
Patients will be asked to track headache frequency, intensity, sleep, and acute medication use on the app. They will also receive written educational material about migraine. Smartphone-Based Progressive Muscle Relaxation Therapy (PMR): Relaxation technique delivered via RELAXaHEAD app. |
| FG001 | Monitored Usual Care (MUC) | Patients will be given a general education session consisting of basic migraine information. They will receive the RELAXaHEAD app but the Progressive Muscle Relaxation Therapy (PMR) function will be blocked. Patients will be asked to track headache frequency, intensity, sleep, and acute medication use on the RELAXaHEAD app. They will also receive written educational material about migraine. Monitored Usual Care (MUC): Standard of care plus daily symptom reporting using the RELAXaHEAD app electronic diary. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RELAX | Patients will receive Progressive Muscle Relaxation Therapy (PMR) via the RELAXaHEAD smart-phone app. Patients will be asked to do the following:
Patients will be asked to track headache frequency, intensity, sleep, and acute medication use on the app. They will also receive written educational material about migraine. Smartphone-Based Progressive Muscle Relaxation Therapy (PMR): Relaxation technique delivered via RELAXaHEAD app. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Enrolled in the Study | Measure of feasibility. | Posted | Count of Participants | Participants | Baseline |
|
6 months
All-cause mortality was not assessed in the study population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RELAX | Patients will receive Progressive Muscle Relaxation Therapy (PMR) via the RELAXaHEAD smart-phone app. Patients will be asked to do the following:
Patients will be asked to track headache frequency, intensity, sleep, and acute medication use on the app. They will also receive written educational material about migraine. Smartphone-Based Progressive Muscle Relaxation Therapy (PMR): Relaxation technique delivered via RELAXaHEAD app. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mia T Minen, MD | NYU Langone Health | 212-263-7744 | mia.minen@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 14, 2022 | Dec 18, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| D009103 | Multiple Sclerosis |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Monitored Usual Care (MUC) | Behavioral | Standard of care plus daily symptom reporting using the RELAXaHEAD app electronic diary. |
|
| Month 2 |
| Daily Diary Satisfaction Scores | 5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction. | Month 3 |
| Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants | 4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction | Baseline |
| Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants | 4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction | Week 1 |
| Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants | 4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction | Month 1 |
| Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants | 4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction | Month 2 |
| Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants | 4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction | Month 3 |
| Number of Days RELAX Arm Participants Performed Progressive Muscle Relaxation Therapy (PMR) at Least 5 Minutes/Day | Calculated using the backend analytics in the RELAXaHEAD app. Measure of feasibility. | Up to Month 3 |
| Number of Days Participants Used Diary | Calculated using the backend analytics in the RELAXaHEAD app. Measure of feasibility. | Up to Month 3 |
| BG001 | Monitored Usual Care (MUC) | Patients will be given a general education session consisting of basic migraine information. They will receive the RELAXaHEAD app but the Progressive Muscle Relaxation Therapy (PMR) function will be blocked. Patients will be asked to track headache frequency, intensity, sleep, and acute medication use on the RELAXaHEAD app. They will also receive written educational material about migraine. Monitored Usual Care (MUC): Standard of care plus daily symptom reporting using the RELAXaHEAD app electronic diary. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Monitored Usual Care (MUC) |
Patients will be given a general education session consisting of basic migraine information. They will receive the RELAXaHEAD app but the Progressive Muscle Relaxation Therapy (PMR) function will be blocked. Patients will be asked to track headache frequency, intensity, sleep, and acute medication use on the RELAXaHEAD app. They will also receive written educational material about migraine. Monitored Usual Care (MUC): Standard of care plus daily symptom reporting using the RELAXaHEAD app electronic diary. |
|
|
| Primary | Daily Diary Satisfaction Scores | 5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | Daily Diary Satisfaction Scores | 5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction. | Posted | Mean | Standard Deviation | score on a scale | Week 1 |
|
|
|
| Primary | Daily Diary Satisfaction Scores | 5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction. | Posted | Mean | Standard Deviation | score on a scale | Month 1 |
|
|
|
| Primary | Daily Diary Satisfaction Scores | 5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction. | Posted | Mean | Standard Deviation | score on a scale | Month 2 |
|
|
|
| Primary | Daily Diary Satisfaction Scores | 5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
|
|
|
| Primary | Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants | 4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants | 4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction | Monitored Usual Care (MUC) participants did not have data collected. | Posted | Mean | Standard Deviation | score on a scale | Week 1 |
|
|
|
| Primary | Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants | 4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction | Monitored Usual Care (MUC) participants did not have data collected. | Posted | Mean | Standard Deviation | score on a scale | Month 1 |
|
|
|
| Primary | Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants | 4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction | Monitored Usual Care (MUC) participants did not have data collected. | Posted | Mean | Standard Deviation | score on a scale | Month 2 |
|
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|
| Primary | Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants | 4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction | Monitored Usual Care (MUC) participants did not have data collected. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
|
|
|
| Primary | Number of Days RELAX Arm Participants Performed Progressive Muscle Relaxation Therapy (PMR) at Least 5 Minutes/Day | Calculated using the backend analytics in the RELAXaHEAD app. Measure of feasibility. | Monitored Usual Care (MUC) participants did not have data collected. | Posted | Mean | Standard Deviation | Days | Up to Month 3 |
|
|
|
| Primary | Number of Days Participants Used Diary | Calculated using the backend analytics in the RELAXaHEAD app. Measure of feasibility. | Posted | Mean | Standard Deviation | Days | Up to Month 3 |
|
|
|
| 0 |
| 0 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Monitored Usual Care (MUC) | Patients will be given a general education session consisting of basic migraine information. They will receive the RELAXaHEAD app but the Progressive Muscle Relaxation Therapy (PMR) function will be blocked. Patients will be asked to track headache frequency, intensity, sleep, and acute medication use on the RELAXaHEAD app. They will also receive written educational material about migraine. Monitored Usual Care (MUC): Standard of care plus daily symptom reporting using the RELAXaHEAD app electronic diary. | 0 | 0 | 0 | 24 | 0 | 24 |
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| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |