VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240, United States
Location status: Recruiting
Location contact
Isabella Soreca, MD
CONTACT
Isabella Soreca, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05917119
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.
Interested in participating?
Request Info40 year–65 year
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15240, United States
Location status: Recruiting
Isabella Soreca, MD
CONTACT
Isabella Soreca, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bright light therapy delivered via glasses
Other names: Bright light therapy-Active intervention
sham delivered with bright light therapy glasses to which a neutral density filter has been applied
Other names: sham-Bright light therapy
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
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
Contact information is provided by the study sponsor or research team.
Isabella Soreca, MD
CONTACT
L. A Pisarov
CONTACT
VA Office of Research and Development
Fed
Bright Light Therapy for Residual Daytime Symptoms Associated With Obstructive Sleep Apnea
Acronym: BrightDaysII
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.
Published trials that share one or more normalized conditions with this study.
NCT05594212
Anxiety Disorders, Apnea
Taipei, Peitou, Taiwan
View Trial DetailsNCT01050465
Acne Vulgaris, Acneiform Eruptions
View Trial DetailsNCT02007265
Apnea, Behavior
Toronto, Ontario, Canada
View Trial DetailsNCT07273019
Apnea, Dyssomnias
Bron, France
View Trial Details