Obstructive Sleep ApneaBrightDaysIINCT05917119
Bright Light Therapy for OSA
A study testing BLT and s-BLT in people with Obstructive Sleep Apnea, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- BLT and s-BLT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
Isabella Soreca, MD, 412-688-6000, Isabella.Soreca@va.gov
Isabella Soreca, MD
About this study
Official title: Bright Light Therapy for Residual Daytime Symptoms Associated With Obstructive Sleep Apnea
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.
Read the detailed description
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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- BLT, s-BLT
- Keywords
- Obstructive sleep apnea, CPAP, Residual daytime sleepiness, Depressive symptoms
- Medical subject headings
- Sleep Apnea, Obstructive, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLTOther
Also called Bright light therapy-Active intervention
Bright light therapy delivered via glasses
s-BLTOther
Also called sham-Bright light therapy
sham delivered with bright light therapy glasses to which a neutral density filter has been applied
| Study group | Role | What they receive |
|---|---|---|
| BLT | Experimental | Bright light therapy delivered via glasses Receives: Other: BLT |
| s-BLT | Sham comparator | Sham Bright light therapy Receives: Other: s-BLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Epworth sleepiness scale
self report questionnaire assessing daytime drowsiness and tendency to fall asleep if inactive
Measured: 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
Measured: baseline, week 4 (end of treatment 1), week 8 (end of wash out), week 12 (end of treatment 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start26 Oct 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- single blind crossover design with randomized condition order
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Isabella Soreca, MD, Principal investigator, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917119
- Sponsor's protocol ID
- F4531-R
- Acronym
- BrightDaysII
- Status last verified
- Jan 2026
- First submitted
- 14 Jun 2023
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bright Light Therapy for Residual Daytime Symptoms Associated With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT05917119
- Acronym / sponsor ID
- BrightDaysII / F4531-R
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, CPAP, Residual daytime sleepiness, Depressive symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 26 Oct 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- single blind crossover design with randomized condition order
| Arm | Type | Receives |
|---|---|---|
| BLT | Experimental | Other: BLTBright light therapy delivered via glasses |
| s-BLT | Sham comparator | Other: s-BLTSham Bright light therapy |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- Shift work
- Travel across time zones in the past month
- Narcolepsy
- Regular hypnotics use
- Decompensated congestive heart failure (CHF)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLTAlso: Bright light therapy-Active interventionBright light therapy delivered via glasses | Other | BLT |
| s-BLTAlso: sham-Bright light therapysham delivered with bright light therapy glasses to which a neutral density filter has been applied | Other | s-BLT |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isabella Soreca, MD principal investigator
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BLT and s-BLT in people with Obstructive Sleep Apnea, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabella Soreca, MD ((412) 688-6000, Isabella.Soreca@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.