Fibromyalgia Sleep A to ZZZ Study
ConditionFibromyalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan
About this trial
This research study is testing whether changes in sleep timing and morning light therapy may have an impact on symptoms related to fibromyalgia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Meets 2016 revised diagnostic criteria for fibromyalgia (FM)
Has access to video conferencing (including web cameras and audio) and a private space for the remote study visits.
Disqualifiers
Significant chronic disease
Severe hearing or memory problems
Pending medical leave applications at workplace
Current pregnancy, breastfeeding, or actively trying to get pregnant
Trial design
Design model
Parallel
Treatments tested in this trial
Light Therapy
DeviceParticipants 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.
Sleep Stabilization
BehavioralAll participants will be asked to follow a fixed sleep schedule.
Treatment groups
390 Participants
are divided into 3 treatment groupsGroup A: Light TherapyExperimental treatment 1 intervention
Group B: Sleep StabilizationExperimental treatment 1 intervention
Group C: Control Group, treatment as usualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
baseline (Visit 3, day 8) to post-treatment (Visit 7, approximately day 36).Secondary outcomes
1
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.
Time frame
baseline (Visit 3, day 8) to post-treatment (Visit 7, approximately day 36).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
National Institute of Nursing Research (NINR)
Collaborator
Source ClinicalTrials.gov