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Bright Light Therapy for Residual Daytime Symptoms Associated With Obstructive Sleep Apnea

Bright Light Therapy for Residual Daytime Symptoms Associated With Obstructive Sleep Apnea

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04299009
Enrollment
15
Registered
2020-03-06
Start date
2020-09-01
Completion date
2022-09-13
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

sleep apnea, CPAP, daytime sleepiness, bright light therapy

Brief 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.

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.

Interventions

DEVICEBright light therapy glasses

Bright light therapy delivered through glasses

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of Recruitment and Retentionbaseline to week 9Number of participants recruited, number of participants retained, number of participants with complete data
Epworth Sleepiness Scalepre- treatment=baseline; post-treatment=4 weeksBrief self report questionnaire used to quantify degree of daytime sleepiness. Minimum score is 0,maximum score is 24; values below 10 are considered normal

Secondary

MeasureTime frameDescription
Functional Outcomes of Sleep Questionnaire (FOSQ-10)pre-treatment=baseline; post-treatment=4 weeksAssesses 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

Countries

United States

Participant flow

Pre-assignment details

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

Participants by arm

ArmCount
sBLT Then BLT
sBLT first, followed by BLT
9
BLT Then sBLT
BLT first, followed by sBLT
6
Total15

Baseline characteristics

CharacteristicsBLT Then BLTBLT Then sBLTTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
9 Participants6 Participants15 Participants
Age, Continuous54.8 years
STANDARD_DEVIATION 5
54.8 years
STANDARD_DEVIATION 5
54.8 years
STANDARD_DEVIATION 5
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants1 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
8 Participants5 Participants13 Participants
Sex: Female, Male
Female
2 Participants0 Participants2 Participants
Sex: Female, Male
Male
7 Participants6 Participants13 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 140 / 14
other
Total, other adverse events
1 / 141 / 14
serious
Total, serious adverse events
0 / 140 / 14

Outcome results

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

Time frame: pre- treatment=baseline; post-treatment=4 weeks

ArmMeasureGroupValue (MEAN)Dispersion
sBLT-BLTEpworth Sleepiness ScaleEpworth pretreatment13.2 score on a scaleStandard Deviation 4
sBLT-BLTEpworth Sleepiness ScaleEpworth post treatment12 score on a scaleStandard Deviation 4.9
BLT-sBLTEpworth Sleepiness ScaleEpworth pretreatment12.3 score on a scaleStandard Deviation 4
BLT-sBLTEpworth Sleepiness ScaleEpworth post treatment10.8 score on a scaleStandard Deviation 4
p-value: <0.0595% CI: [-0.3, 5.19]Mixed Models Analysis
Primary

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

ArmMeasureGroupValue (NUMBER)
sBLT-BLTFeasibility of Recruitment and RetentionCompleters8 participants
sBLT-BLTFeasibility of Recruitment and RetentionNumber of subjects with complete data8 participants
BLT-sBLTFeasibility of Recruitment and RetentionCompleters6 participants
BLT-sBLTFeasibility of Recruitment and RetentionNumber of subjects with complete data6 participants
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

Time frame: pre-treatment=baseline; post-treatment=4 weeks

ArmMeasureGroupValue (MEAN)Dispersion
sBLT-BLTFunctional Outcomes of Sleep Questionnaire (FOSQ-10)FOSQ pre treatment24 score on a scaleStandard Deviation 5
sBLT-BLTFunctional Outcomes of Sleep Questionnaire (FOSQ-10)FOSQ post treatment30 score on a scaleStandard Deviation 5.3
BLT-sBLTFunctional Outcomes of Sleep Questionnaire (FOSQ-10)FOSQ pre treatment28.6 score on a scaleStandard Deviation 3.2
BLT-sBLTFunctional Outcomes of Sleep Questionnaire (FOSQ-10)FOSQ post treatment29.5 score on a scaleStandard Deviation 9

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026