Obstructive Sleep ApneaNCT04299009
Bright Light Therapy for Residual Daytime Symptoms Associated With Obstructive Sleep Apnea
A study testing Bright light therapy glasses in people with Obstructive Sleep Apnea, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Bright light therapy glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 13 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
About this study
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.
Read the detailed description
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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Bright light therapy glasses
- Keywords
- sleep apnea, CPAP, daytime sleepiness, bright light therapy
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright light therapy glassesDevice
Also called BLT
Bright light therapy delivered through glasses
| Study group | Role | What they receive |
|---|---|---|
| Retimer bright light therapy glasses | Experimental | active bright light therapy in the green/blue spectrum range Receives: Device: Bright light therapy glasses |
| sham-Retimer bright light therapy glasses | Sham comparator | bright light therapy with light in the red spectrum (not active) Receives: Device: Bright light therapy glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Recruitment and Retention
Number of participants recruited, number of participants retained, number of participants with complete data
Measured: 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
Measured: pre- treatment=baseline; post-treatment=4 weeks
Secondary outcomes (1)
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
Measured: pre-treatment=baseline; post-treatment=4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start1 Sep 2020
- Primary completion13 Sep 2022
- Study completion13 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
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
- NCT04299009
- Sponsor's protocol ID
- E3304-P
- Other IDs
- 1I21RX003304-01A1
- Status last verified
- Jan 2025
- First submitted
- 2 Mar 2020
- Last updated
- 3 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Soreca I, Arnold N, Dombrovski AY. Bright light therapy for CPAP-resistant OSA symptoms. J Clin Sleep Med. 2024 Feb 1;20(2):211-219. doi: 10.5664/jcsm.10840.
PubMed 37767823
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. 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
- NCT04299009
- Acronym / sponsor ID
- E3304-P
- Conditions
- Obstructive Sleep Apnea
- Keywords
- sleep apnea, CPAP, daytime sleepiness, bright light therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 13 Sep 2022 (actual)
- First posted
- 6 Mar 2020 (actual)
- Results
- Posted 3 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retimer bright light therapy glasses | Experimental | Device: Bright light therapy glassesactive bright light therapy in the green/blue spectrum range |
| sham-Retimer bright light therapy glasses | Sham comparator | Device: Bright light therapy glassesbright light therapy with light in the red spectrum (not active) |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- Shift work
- Travel across time zones in the past month
- Narcolepsy
- Congestive heart failure (CHF)
- Poorly controlled diabetes (HgA1c>7%)
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 |
|---|---|---|
| Bright light therapy glassesAlso: BLTBright light therapy delivered through glasses | Device | Retimer bright light therapy glasses, sham-Retimer bright light therapy glasses |
Primary outcome
Feasibility of Recruitment and Retention
Time frame: baseline to week 9
Number of participants recruited, number of participants retained, number of participants with complete data
Epworth Sleepiness Scale
Time frame: pre- treatment=baseline; post-treatment=4 weeks
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
1 secondary outcome
Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Time frame: pre-treatment=baseline; post-treatment=4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37767823Soreca I, Arnold N, Dombrovski AY. Bright light therapy for CPAP-resistant OSA symptoms. J Clin Sleep Med. 2024 Feb 1;20(2):211-219. doi: 10.5664/jcsm.10840.
- 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. This study is not recruiting at the moment.
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 Bright light therapy glasses 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 3 Feb 2025. 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?
Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Recruitment and Retention (time frame: baseline to week 9). 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?
On the ClinicalTrials.gov record for NCT04299009, which also lists 1 linked publication.
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 3 Feb 2025.