Fibromyalgia Sleep A to ZZZ Study

University of Michigan390 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

390

Conditions

Fibromyalgia

Interventions

Light TherapyDEVICE

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.

Sleep StabilizationBEHAVIORAL

All participants will be asked to follow a fixed sleep schedule.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

RECRUITING

Outcomes

Primary Outcomes

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

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).

Central Contacts

Helen Burgess

CONTACT

734-615-8303 bhelen@umich.edu

Data from ClinicalTrials.gov

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