RECRUITING

Bright Light Therapy for OSA

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

Persistent daytime symptoms of sleepiness in individuals with obstructive sleep apnea (OSA) who are using Continuous Positive Airway Pressure (CPAP) are associated with adverse long term medical and functional outcomes. Supplementary exposure to bright light has beneficial effects on sleep quality and daytime vigilance in healthy individuals and it has been increasingly applied in a variety of sleep and neuropsychiatric conditions. This study will explore the role of Bright Light Therapy (BLT), a well-established non-pharmacological intervention for circadian disturbances, for the treatment of residual daytime symptoms of OSA which do not respond to CPAP. BLT will be delivered via therapy glasses in a cross-over design, where each participant will be exposed to active treatment and sham treatment (4 weeks in each arm) in a randomized order. The hypothesis is that participants will demonstrate improvements in the variables of interest during the four-week active treatment portion of the eight-week crossover study, compared to the four-week sham treatment portion.

Official Title

Bright Light Therapy for Residual Daytime Symptoms Associated With Obstructive Sleep Apnea

Quick Facts

Study Start:2024-02-08
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05917119

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:40 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented diagnosis of OSA
  2. * Currently on CPAP or BiPAP for at least 3 months
  3. * with documented adherence (defined as wearing CPAP/BiPAP for \>6h/night on at least 75% of nights), and adequate control of sleep apnea, as indicated by an AHI of 10 or less when on CPAP
  4. * Excessive residual daytime sleepiness (Epworth score \> 10)
  5. * If taking alertness promoting medication, the investigators will require that they are on a stable dose for at least one month prior to entering the study and that they refrain from dose changes while participating in the study
  6. * If already prescribed BLT, subjects must not have used it for at least one month prior to participating
  1. * Shift work
  2. * Travel across time zones in the past month
  3. * Narcolepsy
  4. * Regular hypnotics use
  5. * Decompensated congestive heart failure (CHF)
  6. * Primary central sleep apnea, needing O2 therapy via nasal cannula
  7. * Poorly controlled diabetes (HgA1c\>8%)
  8. * Active substance use disorder
  9. * Dementia
  10. * Untreated bipolar disorder
  11. * the investigators will consider individuals with a diagnosis of bipolar disorder who are currently in treatment and stable
  12. * Macular degeneration, recent lasik surgery (within 3 months)
  13. * Legally blind
  14. * Taking medication that will cause photosensitivity to blue-green light spectrum wavelength
  15. * Already using bright light therapy

Contacts and Locations

Study Contact

Isabella Soreca, MD
CONTACT
(412) 688-6000
Isabella.Soreca@va.gov
L. A Pisarov
CONTACT
(412) 360-2251
Liubomir.Pisarov@va.gov

Principal Investigator

Isabella Soreca, MD
PRINCIPAL_INVESTIGATOR
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Study Locations (Sites)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Isabella Soreca, MD, PRINCIPAL_INVESTIGATOR, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

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 Date2024-02-08
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-02-08
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • Obstructive sleep apnea
  • CPAP
  • Residual daytime sleepiness
  • Depressive symptoms

Additional Relevant MeSH Terms

  • Obstructive Sleep Apnea