Evaluation of Photobiomodulation or Dry Float Therapy on Sleep Quality in Middle-aged and Elderly Individuals.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Changes in total sleep via Oura Ring
研究概览
简要总结
The main objective of this study is to assess the impact of implementing photobiomodulation (PBM) therapy, either localized or whole body, or dry float on sleep quality in middle-aged and elderly individuals experiencing sleep disturbance. As a secondary objective we will analyze the effect of the treatments on other indices of recovery (subjective and objective) via physiological monitoring in middle-aged and elderly individuals experiencing sleep disturbance.
The study will have 2 phases: Phase 1 will last 5 weeks and will serve as baseline data collection of sleep quality. Phase 2 contains the experimental conditions and will last 13 weeks. Cognitive, behavioral, and physiological tests will be done at baseline (week 1) and at the end of experimental period (week 18). Sleep tracking data will be collected daily.
详细描述
In summary the study participants are expected to:
- Wear a study provided smart ring (OURA Ring) through the end of the study period (at least 75% of the total study time) which measures sleep quantity/quality.
- Keep their smart phones nearby and charged while wearing their devices.
- Complete monthly surveys with questions about general well-being until the end of the study period.
- Complete a testing battery consisting of cognitive tests, behavioral and mood questionnaires, qEEG and physical assessments, in the beginning and at the end of the study period.
- Complete the designated experimental condition 2- 3x/week for 12 weeks (at least 75% of the total sessions), if applicable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female between 50-85 years of age
- •Able and willing to give informed consent
- •No significant untreated medical history
排除标准
- •Have no mental or physical conditions that are deemed inappropriate for study participation at investigator's discretion.
研究组 & 干预措施
Whole-Body Photobiomodulation
Light therapy in both the visible and near-infrared range (non-UV) applied to the whole body in a light pod or bed.
干预措施: NovoThor (Device)
Dry Float
Simulates the effects of traditional Float-REST therapy. Instead of contact with salt water, the dry float system has a very thin membrane that cradles the body and provides a warm sensation, similar to that experienced in a traditional flotation tank.
干预措施: ZeroBody (Device)
Localized Photobiomodulation
Light therapy in both the visible and near-infrared range (non-UV) applied locally to only a specific body region.
干预措施: VieLight (Device)
Control
Participants in the control group will be asked to keep their normal daily routine.
结局指标
主要结局
Changes in total sleep via Oura Ring
时间窗: Changes from baseline versus end of study week 18
Oura Ring will be used to track total sleep throughout the study. Increased total sleep values will indicate better quality sleep and decrease total sleep values will indicate poorer sleep.
Changes in resting state electroencephalography (EEG)
时间窗: Changes from baseline versus end of study week 18
Electroencephalography (EEG) analysis looking for alterations in brain activity. A paired samples t-Test will be used to compare power activity at baseline and follow-up.
Changes in the Circadian Sleep Inventory
时间窗: Changes from baseline versus end of study week 18
Evaluate changes in the participants sleeping patterns. Higher values indicate poorer sleep quality.
Changes in the Patient Health Questionnaire (PHQ-9)
时间窗: Changes from baseline versus end of study week 18
Participants will complete the Patient Health Questionnaire (PHQ-9) once a month. The higher the score, the more severe the symptoms of depression. Scores range from 5-9 = mild, 10-14 = moderate, 15-19 = moderate severe, 20-27 severe depression
次要结局
未报告次要终点