At Home Morning Bright Light Treatment for Chronic Nociplastic Pain

University of Michigan1 site in 1 country390 target enrollmentSeptember 27, 2024

ConditionsFibromyalgia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Fibromyalgia
Sponsor: University of Michigan
Enrollment: 390
Locations: 1
Primary Endpoint: Change in Fibromyalgia Impact Questionnaire-Revised (FIQR) score
Status: Recruiting
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

September 27, 2024

End Date

March 2029

Last Updated

10 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Michigan

Responsible Party

Principal Investigator

Helen Burgess

Professor of Psychiatry, Medical School

University of Michigan

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•Significant chronic disease
•Severe hearing or memory problems
•Pending medical leave applications at workplace
•Current pregnancy, breastfeeding, or actively trying to get pregnant
•Night work or travel outside the eastern time zone within 1 month of the study
•Other research participation
•Frequent number of special events during study period (weddings, concerts, exams, etc).

Outcomes

Primary Outcomes

Change in Fibromyalgia Impact Questionnaire-Revised (FIQR) score

Time Frame: 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.