Bright Light Therapy for Residual Daytime Symptoms Associated With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in QIDS score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants are not told which arm is active versus sham
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of OSA
- •Currently on CPAP or BiPAP for at least 3 months
- •with documented adherence (defined as wearing CPAP/BiPAP for >6h/night on at least 75% of nights), and adequate control of sleep apnea, as indicated by an AHI of 10 or less when on CPAP
- •Excessive residual daytime sleepiness (Epworth score > 10)
- •If taking alertness promoting medication, the investigators will require that they are on a stable dose for at least one month prior to entering the study and that they refrain from dose changes while participating in the study
- •If already prescribed BLT, subjects must not have used it for at least one month prior to participating
排除标准
- •Shift work
- •Travel across time zones in the past month
- •Narcolepsy
- •Regular hypnotics use
- •Decompensated congestive heart failure (CHF)
- •Primary central sleep apnea, needing O2 therapy via nasal cannula
- •Poorly controlled diabetes (HgA1c>8%)
- •Active substance use disorder
- •Untreated bipolar disorder
- •the investigators will consider individuals with a diagnosis of bipolar disorder who are currently in treatment and stable
- •Macular degeneration, recent lasik surgery (within 3 months)
- •Legally blind
- •Taking medication that will cause photosensitivity to blue-green light spectrum wavelength
- •Already using bright light therapy
研究组 & 干预措施
s-BLT
Sham Bright light therapy
干预措施: s-BLT (Other)
BLT
Bright light therapy delivered via glasses
干预措施: BLT (Other)
结局指标
主要结局
Change in QIDS score
时间窗: baseline, week 4 (end of treatment 1), week 8 (end of wash out), week 12 (end of treatment 2)
self report assessment of depressive symptoms severity
Change in Epworth sleepiness scale
时间窗: baseline, week 4 (end of treatment 1), week 8 (end of wash out), week 12 (end of treatment 2)
self report questionnaire assessing daytime drowsiness and tendency to fall asleep if inactive
次要结局
未报告次要终点