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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NR021025-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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This research study is testing whether changes in sleep timing and morning light therapy may have an impact on symptoms related to fibromyalgia.
This study will test a consumer health light therapy device (Re-Timer)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Light Therapy | Experimental | All participants will be asked to attend 8 virtual visits over 5 months. Participants randomized to the morning light therapy group are asked to wear the glasses for 1 hour per day. The timing of each person's therapy is tailored to their average wake up time during a baseline period. The treatment period is 4 weeks long. |
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| Sleep Stabilization | Experimental | All participants will be asked to attend 8 virtual visits over 5 months. Participants randomized to the sleep stabilization arm are asked to follow a fixed sleep schedule tailored to their sleep during a baseline period. The treatment period is 4 weeks. |
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| Control Group, treatment as usual | No Intervention | Participants will be asked to sleep as per usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Light Therapy | Device | Participants will self-administer the daily light therapy within a few minutes of their assigned wake up time for one hour. Researchers will provide a light log to note light on/off times, any interruptions to light therapy, and primary activity during light therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fibromyalgia Impact Questionnaire-Revised (FIQR) score | The FIQR is 21 questions. Each question has 11 boxes similar to a visual analog scale. Questions include the difficulty associated with various physical activities and the severity of symptoms. The score for the questions is on a scale from 0 - 100, where lower scores represented better functional status. | baseline (Visit 3, day 8) to post-treatment (Visit 7, approximately day 36). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brief Pain Inventory (BPI) score | The BPI consists of 11 questions and assesses for the presence of pain, pain intensity (i.e., worst, least, average, current) and functional interference from pain. A higher score indicates more pain. | baseline (Visit 3, day 8) to post-treatment (Visit 7, approximately day 36). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helen Burgess | Contact | 734-615-8303 | bhelen@umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Afton Hassett | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40880266 | Derived | Burgess HJ, Rodgers AA, McNeil KA, Mott J, Fejer A, Dereski T, Rizvydeen M, Sibille KT, Kim HM, Cofield C, Burns JW, Shaikh S, Hassett AL. At-Home Morning Bright Light Treatment for Chronic Nociplastic Pain: Protocol for a Randomized Clinical Trial. JMIR Res Protoc. 2025 Oct 13;14:e75060. doi: 10.2196/75060. |
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After the study is completed, the de-identified, archived data will be transmitted to and stored at the NHLBI National Sleep Research Resource (NSRR) data repository.
From study completion and up to 7 years following publication.
Members of the scientific community who would like a copy of the final data sets (i.e., data sets underlying any publication) from this study can request a copy by contacting the principal investigators and/or NSRR.
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D010789 | Phototherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Sleep Stabilization | Behavioral | All participants will be asked to follow a fixed sleep schedule. |
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| D009422 |
| Nervous System Diseases |