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

NCT04299009 | Completed Results

• 2 other identifiers: E3304-P1I21RX003304-01A1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

sleep apnea; CPAP; daytime sleepiness; bright light therapy

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Functional Outcomes of Sleep Questionnaire (FOSQ-10)

  pre-treatment=baseline; post-treatment=4 weeks

Study Arms (2)

Retimer bright light therapy glasses

EXPERIMENTAL

active bright light therapy in the green/blue spectrum range

Device: Bright light therapy glasses

sham-Retimer bright light therapy glasses

SHAM COMPARATOR

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

Device: Bright light therapy glasses

Interventions

Bright light therapy glasses DEVICE

Bright light therapy delivered through glasses

Also known as: BLT

Retimer bright light therapy glasses; sham-Retimer bright light therapy glasses

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Publications (1)

• 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.

  PMID: 37767823 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Isabella Soreca
• Organization: Pittsburgh VA Healthcare System

Isabella.Soreca@va.gov

412 3606815

Study Officials

• Isabella Soreca, MD

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 6, 2020
• Study Start: September 1, 2020
• Primary Completion: September 13, 2022
• Study Completion: September 13, 2022
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)