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NCT Number: NCT06567886

Fibromyalgia Sleep A to ZZZ Study

This research study is testing whether changes in sleep timing and morning light therapy may have an impact on symptoms related to fibromyalgia.

Recruiting

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48105, United States

Location status: Recruiting

Location contact

Afton Hassett, PsyD

PRINCIPAL_INVESTIGATOR

Helen Burgess

CONTACT

[email protected]

734-615-8303

Helen Burgess, PhD

PRINCIPAL_INVESTIGATOR

About this study

This study will test a consumer health light therapy device (Re-Timer)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: Re-Timer

Sleep Stabilization

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Brief Pain Inventory (BPI) score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Helen Burgess

CONTACT

[email protected]

734-615-8303

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

At Home Morning Bright Light Treatment for Chronic Nociplastic Pain

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Aug 23, 2024
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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