An interventional study of Bright light therapy glasses in Obstructive Sleep Apnea, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 50 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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.
Due to COVID-19 pandemic emergency measures, recruitment for clinical trials is currently on hold
Background: Sleep apnea is one of the most common chronic condition among US military Veterans , it causes sleepiness, reduced psychomotor vigilance and depression, which undermine daytime functioning and quality of life . Persistent daytime symptoms of sleepiness and depression in individuals with OSA who are using Continuous Positive Airway Pressure (CPAP) are associated with adverse long term medical and functional outcomes . Current treatment options are limited to stimulants and modafinil, whose long-term safety profile, effectiveness and impact on functional recovery is largely unknown. The mechanisms for residual daytime symptoms in CPAP-treated sleep apnea are poorly understood and very little attention has been placed on interplay between sleep apnea and the circadian system. Notably, sleepiness, fatigue and depression, cardinal symptoms of OSA syndrome, are common manifestations of circadian misalignment. Circadian rhythms are synchronized to the environmental light or dark and to social activity cycles by zeitgebers (time givers) .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. 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.
2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.
This study's enrollment of 15 is below the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →VA Office of Research and Development is the lead sponsor of 1,767 studies on the registry; 394 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 183 (88%) have results posted.
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Exclusion Criteria:
active bright light therapy in the green/blue spectrum range
Device: Bright light therapy glasses
bright light therapy with light in the red spectrum (not active)
Device: Bright light therapy glasses
Bright light therapy delivered through glasses
Also known as: BLT
Feasibility of Recruitment and Retention
Number of participants recruited, number of participants retained, number of participants with complete data
Time frame: baseline to week 9
Epworth Sleepiness Scale
Brief self report questionnaire used to quantify degree of daytime sleepiness. Minimum score is 0,maximum score is 24; values below 10 are considered normal
Time frame: pre- treatment=baseline; post-treatment=4 weeks
Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Assesses impact of sleep related disturbances on daily functioning. It is a likert scale whose scaling of items is from zero to four. The potential range of scores for the total score is 5-20, with higher scores indicating worse functioning
Time frame: pre-treatment=baseline; post-treatment=4 weeks
| Milestone | Sham-Bright Light Therapy (sBLT) First, Then BLT | Bright Light Therapy (BLT) First, Then sBLT |
|---|---|---|
| Started | 9 | 6 |
| Completed | 8 | 6 |
| Not completed | 1 | 0 |
| Milestone | Sham-Bright Light Therapy (sBLT) First, Then BLT | Bright Light Therapy (BLT) First, Then sBLT |
|---|---|---|
| Started | 8 | 6 |
| Completed | 8 | 6 |
| Not completed | 0 | 0 |
Number of participants recruited, number of participants retained, number of participants with complete data
| participants | sBLT-BLT | BLT-sBLT |
|---|---|---|
| Completers | 8 | 6 |
| Number of subjects with complete data | 8 | 6 |
Brief self report questionnaire used to quantify degree of daytime sleepiness. Minimum score is 0,maximum score is 24; values below 10 are considered normal
| score on a scale | sBLT | BLT, Active Treatment |
|---|---|---|
| Epworth pretreatment | 13.2 ± 4 | 12.3 ± 4 |
| Epworth post treatment | 12 ± 4.9 | 10.8 ± 4 |
Assesses impact of sleep related disturbances on daily functioning. It is a likert scale whose scaling of items is from zero to four. The potential range of scores for the total score is 5-20, with higher scores indicating worse functioning
| score on a scale | sBLT | BLT Active Treatment |
|---|---|---|
| FOSQ pre treatment | 24 ± 5 | 28.6 ± 3.2 |
| FOSQ post treatment | 30 ± 5.3 | 29.5 ± 9 |
Collected over Each participants was assessed for a total of 10 weeks max from consent signing to end of the study.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sham-Bright Light Therapy (sBLT) | 0/14 (0%) | 0/14 (0%) | 1/14 (7.1%) |
| Bright Light Therapy (BLT) | 0/14 (0%) | 0/14 (0%) | 1/14 (7.1%) |
| Event | Sham-Bright Light Therapy (sBLT) | Bright Light Therapy (BLT) |
|---|---|---|
| HeadacheGeneral disorders | 1/14 | 1/14 |
| Age, Categorical(Participants) | sBLT Then BLT | BLT Then sBLT | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 9 | 6 | 15 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | sBLT Then BLT | BLT Then sBLT | Total |
|---|---|---|---|
| Mean | 54.8 ± 5 | 54.8 ± 5 | 54.8 ± 5 |
| Sex: Female, Male(Participants) | sBLT Then BLT | BLT Then sBLT | Total |
|---|---|---|---|
| Female | 2 | 0 | 2 |
| Male | 7 | 6 | 13 |
| Race (NIH/OMB)(Participants) | sBLT Then BLT | BLT Then sBLT | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 8 | 5 | 13 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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