ENROLLING_BY_INVITATION

Study of Circadian Focused Light Therapy in Progressive Multiple Sclerosis

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Conditions

Progressive Multiple SclerosisFatigueSleepinessCircadian

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study is being done to determine if treatment with a novel form of light therapy is tolerated in patients with progressive multiple sclerosis. The goal of this trial to establish the safety profile of this light therapy while generating data on its impact on fatigue, as well as its mechanism of action. Fatigue is often a complex symptom in multiple sclerosis, without any FDA-approved direct therapy. Fatigue is traditionally treated with symptom management through a multidisciplinary team.

Official Title

A Phase I Study of Circadian Focused Light Therapy for Fatigue Reduction in Progressive Multiple Sclerosis (NO-FATIGUE)

Quick Facts

Study Start:2024-04-18
Study Completion:2026-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ENROLLING_BY_INVITATION

Study ID

NCT06261528

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years old
  2. * Diagnosis of PPMS or SPMS according to the 2017, or 2010 Revised McDonald Criteria
  3. * In the opinion of the investigator, able to complete study procedures
  4. * Epworth Sleepiness Scale (ESS) ≥ 9
  5. * Must be on a stable dose of an FDA-approved disease modifying therapy for at least 3 months prior to screening
  6. * Pharmacological and non-pharmacological mood and fatigue treatments must be stable for the previous three months prior to screening and must have intent to keep these stable for the duration of study treatment
  1. * Sleep onset latency under 15 minutes
  2. * Pharmacological and non-pharmacological mood and fatigue treatments changes within the previous three months prior to screening
  3. * Based on the Investigator's judgement, patients with a history of significant other medical condition that may interfere with the conduct of the study, or interpretation of the study results
  4. * History of any clinically significant abnormality in hematology, blood chemistry, or examination not resolved by the baseline visit which according to the investigator can interfere with study participation
  5. * Positive drug screen for cocaine, or phencyclidine, or known alcohol abuse within 30 days of the trial
  6. * Females who are pregnant, have a provided recent positive pregnancy test, are nursing, or who plan to get pregnant during the course of this clinical trial
  7. * Patient taking melatonin analogues without appropriate washout, defined as five half-lives of the medication, or within 14 days of screening, whichever is longer
  8. * No new or adjusted prescription medication within 14 days of the baseline
  9. * An investigator verified MS relapse within the previous year
  10. * Presence of a gadolinium-enhancing demyelinating lesion within the last year
  11. * Optic neuritis within the previous 3 months
  12. * Sleep schedule changes as required by employment (night shifts)
  13. * Travel across two time zones within 3 months of study screening

Contacts and Locations

Principal Investigator

Peter Sguigna, MD
PRINCIPAL_INVESTIGATOR
UTSW

Study Locations (Sites)

UT Southwestern Medical Center
Dallas, Texas, 75247
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Peter Sguigna, MD, PRINCIPAL_INVESTIGATOR, UTSW

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-18
Study Completion Date2026-07-01

Study Record Updates

Study Start Date2024-04-18
Study Completion Date2026-07-01

Terms related to this study

Keywords Provided by Researchers

  • Fatigue
  • Sleepiness
  • Circadian

Additional Relevant MeSH Terms

  • Progressive Multiple Sclerosis