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NCT Number: NCT05917119

Bright Light Therapy for OSA

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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location status: Recruiting

Location contact

Isabella Soreca, MD

CONTACT

[email protected]

412-688-6000

Isabella Soreca, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Documented diagnosis of OSA
  • Currently on CPAP or BiPAP for at least 3 months
  • 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
  • Excessive residual daytime sleepiness (Epworth score > 10)
  • 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
  • If already prescribed BLT, subjects must not have used it for at least one month prior to participating

Exclusion criteria

  • Shift work
  • Travel across time zones in the past month
  • Narcolepsy
  • Regular hypnotics use
  • Decompensated congestive heart failure (CHF)
  • Primary central sleep apnea, needing O2 therapy via nasal cannula
  • Poorly controlled diabetes (HgA1c>8%)
  • Active substance use disorder
  • Dementia
  • Untreated bipolar disorder
  • the investigators will consider individuals with a diagnosis of bipolar disorder who are currently in treatment and stable
  • Macular degeneration, recent lasik surgery (within 3 months)
  • Legally blind
  • Taking medication that will cause photosensitivity to blue-green light spectrum wavelength
  • Already using bright light therapy

Treatment and study plan

BLT

Other

Bright light therapy delivered via glasses

Other names: Bright light therapy-Active intervention

s-BLT

Other

sham delivered with bright light therapy glasses to which a neutral density filter has been applied

Other names: sham-Bright light therapy

Primary outcomes

  1. Change in Epworth sleepiness scale

    Time frame: baseline, week 4 (end of treatment 1), week 8 (end of wash out), week 12 (end of treatment 2)

    self report questionnaire assessing daytime drowsiness and tendency to fall asleep if inactive

  2. Change in QIDS score

    Time frame: baseline, week 4 (end of treatment 1), week 8 (end of wash out), week 12 (end of treatment 2)

    self report assessment of depressive symptoms severity

Study contacts

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

Isabella Soreca, MD

CONTACT

[email protected]

(412) 688-6000

L. A Pisarov

CONTACT

[email protected]

(412) 360-2251

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: BrightDaysII

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 23, 2023
Registry last updated
Jan 9, 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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