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| ID | Type | Description | Link |
|---|---|---|---|
| 1I21RX003304-01A1 | U.S. NIH Grant/Contract | View source |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retimer bright light therapy glasses | Experimental | active bright light therapy in the green/blue spectrum range |
|
| sham-Retimer bright light therapy glasses | Sham Comparator | bright light therapy with light in the red spectrum (not active) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bright light therapy glasses | Device | Bright light therapy delivered through glasses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Recruitment and Retention | Number of participants recruited, number of participants retained, number of participants with complete data | 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 | pre- treatment=baseline; post-treatment=4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | pre-treatment=baseline; post-treatment=4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 | Pittsburgh | Pennsylvania | 15240 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37767823 | Derived | 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. |
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The available effective window for recruitment of participants was drastically reduced by the pandemic, during which all research activities and non essential clinical contact was place on hold
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham-Bright Light Therapy (sBLT) First, Then BLT | Participants received sBLT therapy via Retimer glasses with a neutral density filter applied to the led lights, thus blocking 85% of the light intensity for 4 weeks, followed by BLT |
| FG001 | Bright Light Therapy (BLT) First, Then sBLT | Participants received BLT via Retimer glasses for 4 weeks, followed by 4 weeks of sBLT |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (4 Weeks) |
| |||||||||||||
| Second Intervention (4 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | sBLT Then BLT | sBLT first, followed by BLT |
| BG001 | BLT Then sBLT | BLT first, followed by sBLT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Recruitment and Retention | Number of participants recruited, number of participants retained, number of participants with complete data | Posted | Number | participants | baseline to week 9 |
|
|
Each participants was assessed for a total of 10 weeks max from consent signing to end of the study.
consistent with clinicaltrials.gov definition
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham-Bright Light Therapy (sBLT) | sham bright light therapy first, follow by one week wash out and them active bright light therapy Active treatment: Bright light therapy delivered through Retimer glasses. Sham treatment: neutral density filter blocking 80% of light intensity applied to Retimer glasses. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Isabella Soreca | Pittsburgh VA Healthcare System | 412 3606815 | Isabella.Soreca@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 11, 2020 | Oct 19, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 27, 2021 | May 18, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| D006970 | Disorders of Excessive Somnolence |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| NOT COMPLETED |
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| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | score on a scale | pre- treatment=baseline; post-treatment=4 weeks |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | pre-treatment=baseline; post-treatment=4 weeks |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 1 |
| 14 |
| EG001 | Bright Light Therapy (BLT) | active bright light therapy first, followed by one week wash out and then sham Bright light therapy Active treatment: Bright light therapy delivered through Retimer glasses. Sham treatment: neutral density filter blocking 85% of light intensity applied to Retimer glasses. | 0 | 14 | 0 | 14 | 1 | 14 |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |