N/A
N=15
Bright Light Therapy for Residual Daytime Symptoms Associated With Obstructive Sleep Apnea
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT04299009 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Feasibility of Recruitment and Retention — 8; 6; 8; 6 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bright light therapy glasses (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Recruitment and Retention |
8; 6; 8; 6 | — |
| PRIMARY Epworth Sleepiness Scale |
13.2; 12.3; 12; 10.8 | <0.05 sig |
| SECONDARY Functional Outcomes of Sleep Questionnaire (FOSQ-10) |
24; 28.6; 30; 29.5 | — |
Summary
Sleep apnea is one of the most common chronic condition among US military Veterans, causing sleepiness, reduced psychomotor vigilance and depression, which undermine daytime functioning and quality of life. 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. Residual daytime sleepiness (RDS) is associated with reduced occupational and family functioning and overall lower quality of life. Napping is a common behavior among individuals with OSA and RDS and has been linked to both benefits to and decline in health and functioning. Longer nap times may maintain, as opposed to decrease, sleepiness by promoting sleep inertia and can contribute to maintaining subclinical circadian alterations that result in higher night-tonight variability in sleep patterns. Preliminary studies in humans and animal models have shown persisting alterations of circadian rhythms in OSA patients, that fail to normalize with CPAP treatment. CPAP treatment, while effective at correcting respiratory events and night time blood oxygen saturation levels, does not necessarily re-align the circadian system. Current treatment options are limited to stimulants and modafinil, whose long-term safety profile, effectiveness and impact on functional recovery is largely unknown. 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. However, no study to date has tested the application of BLT to treat daytime symptoms associated with sleep apnea. The investigators' study will be the first to 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.
Eligibility Criteria
Inclusion Criteria
- Veterans from the VA Pittsburgh Healthcare System (VAPHS)
- Documented diagnosis of OSA
- Currently on CPAP or BiPAP with documented adherence (defined as wearing CPAP/BiPAP for >4h/night on at least 75% of nights)
- Excessive residual daytime sleepiness (Epworth score > 10)
- Endorsing depressive symptoms (Quick Inventory of Depressive Symptomatology (Self-Report) [QIDS-SR] score>8)
Exclusion Criteria
- Shift work
- Travel across time zones in the past month
- Narcolepsy
- Congestive heart failure (CHF)
- Poorly controlled diabetes (HgA1c>7%)
- Active substance use disorder
- Dementia
- Bipolar disorder
Data sourced from ClinicalTrials.gov (NCT04299009). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.