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

NCT ID: NCT04299009

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-09-13

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Retimer bright light therapy glasses

active bright light therapy in the green/blue spectrum range

Group Type: EXPERIMENTAL

Bright light therapy glasses

Intervention Type: DEVICE

Bright light therapy delivered through glasses

sham-Retimer bright light therapy glasses

bright light therapy with light in the red spectrum (not active)

Group Type: SHAM_COMPARATOR

Bright light therapy glasses

Intervention Type: DEVICE

Bright light therapy delivered through glasses

Interventions

Bright light therapy glasses

Bright light therapy delivered through glasses

Intervention Type: DEVICE

Other Intervention Names

BLT

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Isabella Soreca, MD

Role: PRINCIPAL_INVESTIGATOR

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Locations

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37767823 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1I21RX003304-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

E3304-P

Identifier Type: -

Identifier Source: org_study_id