Bright Light Therapy for Sleep Apnea
(BrightDaysII Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Must not be taking: Hypnotics, Photosensitivity drugs
Disqualifiers: Shift work, Narcolepsy, CHF, Diabetes, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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. 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. This study will 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. BLT will be delivered via therapy glasses in a cross-over design, where each participant will be exposed to active treatment and sham treatment (4 weeks in each arm) in a randomized order. The hypothesis is that participants will demonstrate improvements in the variables of interest during the four-week active treatment portion of the eight-week crossover study, compared to the four-week sham treatment portion.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are on alertness-promoting medication, you must be on a stable dose for at least one month before the study and not change the dose during the study.
What data supports the effectiveness of the treatment Bright Light Therapy for Sleep Apnea?
A study on bright light therapy (BLT) showed it might help improve sleep and reduce daytime sleepiness in people with sleep apnea who don't fully benefit from CPAP (a common sleep apnea treatment). This suggests BLT could be a useful addition to managing sleep apnea symptoms.
12345Is bright light therapy safe for humans?
Bright light therapy (BLT) is generally well-tolerated with few side effects. Some studies report minor issues like blurring, but serious side effects are rare, making it a safe option for many people.
678910How is bright light therapy different from other treatments for sleep apnea?
Bright light therapy is unique because it uses exposure to bright light to help align sleep-wake cycles, which can be beneficial for conditions with disrupted circadian rhythms. Unlike other treatments for sleep apnea that may involve devices or medications, this therapy focuses on adjusting the body's internal clock through light exposure, making it a non-invasive option.
67101112Eligibility Criteria
This trial is for individuals with obstructive sleep apnea (OSA) who still feel very sleepy during the day despite using CPAP machines regularly. They must have used their CPAP for at least 3 months, not have central sleep apnea or certain other health conditions, and cannot be on medications that affect light sensitivity.Inclusion Criteria
I haven't used BLT for at least one month.
You have been using CPAP or BiPAP for at least 3 months, wearing it for more than 6 hours a night on most nights, and your sleep apnea is well controlled with an AHI of 10 or less when using the device.
I often feel very sleepy during the day.
+2 more
Exclusion Criteria
I have central sleep apnea and need oxygen therapy through my nose.
I do not have worsening heart failure that requires hospitalization.
You are currently addicted to drugs or alcohol.
+12 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Bright Light Therapy and Sham Bright Light Therapy in a crossover design, each for 4 weeks
8 weeks
Visits at baseline, week 4, week 8, and week 12
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests Bright Light Therapy (BLT) to see if it helps reduce daytime sleepiness in OSA patients who use CPAP. Participants will try both real BLT and a fake version without knowing which is which, each for four weeks, to compare effects.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BLTExperimental Treatment1 Intervention
Bright light therapy delivered via glasses
Group II: s-BLTPlacebo Group1 Intervention
Sham Bright light therapy
Bright Light Therapy (BLT) is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Bright Light Therapy for:
- Seasonal Affective Disorder (SAD)
- Non-seasonal depression
- Circadian rhythm sleep disorders
- Insomnia
🇪🇺 Approved in European Union as Bright Light Therapy for:
- Seasonal Affective Disorder (SAD)
- Non-seasonal depression
- Circadian rhythm sleep disorders
- Insomnia
🇨🇦 Approved in Canada as Bright Light Therapy for:
- Seasonal Affective Disorder (SAD)
- Non-seasonal depression
- Circadian rhythm sleep disorders
- Insomnia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PAPittsburgh, PA
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Bright light therapy for CPAP-resistant OSA symptoms. [2023]Sleep fragmentation and daytime sleepiness often persist in patients with sleep apnea despite correctly administered CPAP. Our proof-of-concept study tested acceptability and efficacy of morning bright light therapy (BLT) to improve sleep, circadian rhythms and CPAP-resistant daytime symptoms in patients with sleep apnea.
Can we enhance compliance to treatment by performing a continuous positive airway pressure trial in obstructive sleep apnea? [2022]Although continuous positive airway pressure (CPAP) therapy is the most effective treatment for obstructive sleep apnea (OSA), it is not always easy to gain adherence to therapy. We aimed to evaluate how short-term CPAP application during the daytime before the titration night affects polysomnographic data and CPAP adherence in OSA.
Redefining the timing of surgery for obstructive sleep apnea in anatomically favorable patients. [2022]Healthcare remunerating agencies in North America require patients with obstructive sleep apnea (OSA) to undergo a continuous positive airway pressure (CPAP) trial before funding surgical therapy. The adherence rate of CPAP is problematic. This study's objective was to determine the proportion of surgically favorable patients who failed CPAP who subsequently benefitted from surgical therapy, and to explore consideration of surgical therapy as first-line treatment in this specific OSA subpopulation.
When to suspect obstructive sleep apnea syndrome. Symptoms may be subtle, but treatment is straightforward. [2019]OSAS is a serious, prevalent condition that has significant mortality and morbidity when untreated. It is easy to diagnose and treat. Treatment improves quality of life and prevents associated morbidity or death. Response to treatment is high. The goal is to keep the airway open during sleep, leading to improved sleep, better oxygenation, and enhanced day-time alertness. The treatment of choice is CPAP, although bilevel positive airway pressure devices may be used in patients unable to tolerate CPAP. Many surgical treatments have proved effective. Drug therapy may be useful. Weight loss and training to avoid the supine sleeping position are helpful for some patients.
Treatment outcome of sleep apnea. [2007]Two hundred one patients diagnosed as having obstructive sleep apnea (OSA) were interviewed 12-24 months after their evaluation regarding those daytime symptoms associated with sleep apnea: sleepiness, fatigue, impaired memory, and snoring. Continuous positive airway pressure (CPAP) was the treatment most often used by severe sleep apnea patients, and this improved daytime alertness in 84% of the patients. Patients with moderate obstructive sleep apnea often had surgery which led to 85% reporting improved daytime alertness. Patients with mild obstructive sleep apnea usually were treated with weight loss or changing sleep position and also improved 64% and 66%. Patients who declined or failed treatment did not improve. Guidelines for the treatment of sleep apnea are suggested.
[Bright light therapy in pregnant women depression--3 case studies]. [2006]Bright light therapy (BLT) is a new method of biological treatment in psychiatry. Good tolerance makes it an attractive method used not only in seasonal affective disorder. An episode of depression during pregnancy may be a new indication. The study aimed to describe effects of treatment of depression in 3 pregnant women.
Paranoid delusions and hallucinations and bright light therapy in Alzheimer's disease. [2022]Bright light therapy (BLT) is becoming increasingly popular as an adjunct in the treatment of non-SAD depression and circadian rhythm disturbances in demented patients. Although the rate of side-effects is low, special attention should be paid when treating new groups of patients. We present the case of an 80-year-old woman suffering from dementia of Alzheimer's type (DAT).
Bright light therapy: Minimizing light induced side effects with an innovative light setup. [2014]Abstract Objective. Bright light therapy (BLT) is regarded to be an effective treatment against seasonal depression (SAD). Conventional BLT devices are reported to evoke few, but inconvenient symptoms. This study evaluated side effects associated with a new technology for BLT in a healthy population. Methods. In an uncontrolled study design 20 healthy Caucasians received 30 min light exposures on three consecutive mornings. Immediate side effects were evaluated using questionnaires. The new light cabin was equipped with fluorescent lamps (light colour 965 = 6,500 K, CRI >90) with a maximum illumination of 5,000 lux and a maximum luminance of 1,500 cd/m(2). Occurrence of headache was determined to be the main objective. Results. Nineteen volunteers completed the study. No headache was reported at any time. With a prevalence of 21.1% blurring was observed to occur more often after light exposure. Conclusion. With the evaluated light cabin the most prominent short-term side effects of BLT can be minimized, enhancing patients' adherence.
Is there a difference in clinical efficacy of bright light therapy for different types of depression? A pilot study. [2018]There is growing interest in the possible applications of Bright Light Therapy (BLT). BLT might be a valid alternative or add-on treatment for many other psychiatric disorders beyond seasonal affective disorder. This pilot study aims to examine whether the efficacy of Bright Light Therapy (BLT) is similar for different subtypes of mood disorders.
The effect of bright light therapy on sleep and circadian rhythms in renal transplant recipients: a pilot randomized, multicentre wait-list controlled trial. [2016]This study assessed the effect and feasibility of morning bright light therapy (BLT) on sleep, circadian rhythms, subjective feelings, depressive symptomatology and cognition in renal transplant recipients (RTx) diagnosed with sleep-wake disturbances (SWD). This pilot randomized multicentre wait-list controlled trial included 30 home-dwelling RTx randomly assigned 1:1 to either 3 weeks of BLT or a wait-list control group. Morning BLT (10 000 lux) was individually scheduled for 30 min daily for 3 weeks. Wrist actimetry (measuring sleep and circadian rhythms), validated instruments (subjective feelings and cognition) and melatonin assay (circadian timing) were used. Data were analysed via a random-intercept regression model. Of 30 RTx recipients (aged 58 ± 15, transplanted 15 ± 6 years ago), 26 completed the study. While BLT had no significant effect on circadian and sleep measures, sleep timing improved significantly. The intervention group showed a significant get-up time phase advance from baseline to intervention (+24 min) [(standardized estimates (SE): -0.23 (-0.42; -0.03)] and a small (+14 min) but significant bedtime phase advance from intervention to follow-up (SE: -0.25 (-0.41; -0.09). Improvement in subjective feelings and depressive symptomatology was observed but was not statistically significant. Bright light therapy showed preliminary indications of a beneficial effect in RTx with sleep-wake disturbances. (ClinicalTrials.gov number: NCT01256983).
[Photoperiod phototherapy and wakefulness-sleep rhythm disorders]. [2006]Bright light therapy is a recent physical treatment in chronodisabled situations. The most recognized indication is the seasonal affective disorder. However, any disease or dysfunction where a misalignment of sleep-wake and circadian rhythms may be suspected is a potential tool for this treatment. Analyses of the literature throughout the interpretation methods of the evidence based medicine indicate that bright light therapy, if not a standard, could be recommended in a number of circadian rhythm sleep disorders, mainly the delayed and advanced sleep phase syndromes. Time aspects are essential for the success of phototherapy. From this point of view, easy and practical technological means or methods, allowing to shape a Phase Response Curve in each individual to be treated, should be clear progress. A future extension of indications will also depend on the checking of essential hypotheses linking circadian and sleep-wake rhythms in diseases such as psychophysiological insomnia, multiple sclerosis, brain dysgeneses or dementias. At last, a non negligible advantage of bright light therapy appears to be its relative safety.
Feasibility of Adjunctive Bright Light Therapy for Depressive Symptoms on an Acute Psychiatric Floor. [2023]Bright light therapy (BLT) has been increasingly used as an experimental treatment in non-seasonal unipolar depression. While clinical trials have demonstrated the efficacy of BLT in ameliorating depression for outpatients, studies examining BLT in the psychiatric inpatient setting are currently lacking.