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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BLT | Experimental | Bright light therapy delivered via glasses |
|
| s-BLT | Sham Comparator | Sham Bright light therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLT | Other | Bright light therapy delivered via glasses |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Epworth sleepiness scale | self report questionnaire assessing daytime drowsiness and tendency to fall asleep if inactive | baseline, week 4 (end of treatment 1), week 8 (end of wash out), week 12 (end of treatment 2) |
| Change in QIDS score | self report assessment of depressive symptoms severity | baseline, week 4 (end of treatment 1), week 8 (end of wash out), week 12 (end of treatment 2) |
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Inclusion Criteria:
Documented diagnosis of OSA
Currently on CPAP or BiPAP for at least 3 months
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
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabella Soreca, MD | Contact | (412) 688-6000 | Isabella.Soreca@va.gov | |
| L. A Pisarov | Contact | (412) 360-2251 | Liubomir.Pisarov@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Isabella Soreca, MD | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Recruiting | Pittsburgh | Pennsylvania | 15240 | United States |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D003863 | Depression |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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single blind crossover design with randomized condition order
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Participants are not told which arm is active versus sham
| s-BLT | Other | sham delivered with bright light therapy glasses to which a neutral density filter has been applied |
|
|
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |