Fibromyalgia
Conditions
Keywords
Sleep timing stabilization, Morning light therapy
Brief summary
This research study is testing whether changes in sleep timing and morning light therapy may have an impact on symptoms related to fibromyalgia.
Detailed description
This study will test a consumer health light therapy device (Re-Timer)
Interventions
DEVICELight Therapy
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.
BEHAVIORALSleep Stabilization
All participants will be asked to follow a fixed sleep schedule.
Sponsors
University of Michigan
National Institute of Nursing Research (NINR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Meets 2016 revised diagnostic criteria for fibromyalgia (FM) 2. Has access to video conferencing (including web cameras and audio) and a private space for the remote study visits.
Exclusion criteria
1. Significant chronic disease 2. Severe hearing or memory problems 3. Pending medical leave applications at workplace 4. Current pregnancy, breastfeeding, or actively trying to get pregnant 5. Night work or travel outside the eastern time zone within 1 month of the study 6. Other research participation 7. Frequent number of special events during study period (weddings, concerts, exams, etc).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fibromyalgia Impact Questionnaire-Revised (FIQR) score | baseline (Visit 3, day 8) to post-treatment (Visit 7, approximately day 36). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brief Pain Inventory (BPI) score | baseline (Visit 3, day 8) to post-treatment (Visit 7, approximately day 36). | 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. |
Countries
United States
Contacts
CONTACTHelen Burgess
PRINCIPAL_INVESTIGATORAfton Hassett
University of Michigan
Outcome results
None listed