Translational Research on Acupuncture Modulation of Sleep Fragmentation and Glymphatic Function in Aging: A Single-Arm Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in 7-day mean wake after sleep onset from baseline to Week 6
研究概览
简要总结
This single-group pilot study will enroll 20 adults aged 60 years or older with persistent poor sleep. All participants will receive a standardized 6-week acupuncture program. The study will assess feasibility and preliminary changes in actigraphy-derived sleep fragmentation, self-reported sleep, brain DTI-ALPS imaging, internal jugular venous ultrasonography, and CERAD-NB word-list memory performance.
详细描述
After written informed consent, participants will complete cognitive and mood screening. Baseline assessments include PSQI, ISI, ESS, CERAD-NB word-list memory testing, one night of home polysomnography, 7 days of actigraphy, brain MRI for the DTI-ALPS index, and internal jugular venous ultrasonography. Participants will then receive acupuncture twice weekly for 6 weeks, for 12 sessions, with each session lasting approximately 20 to 30 minutes. ISI will also be assessed at Weeks 2 and 4. At Week 6, baseline assessments will be repeated except for home polysomnography. PSQI, ISI, and ESS will be collected again approximately 3 months after treatment as an optional follow-up. Missing data from this optional follow-up alone will not exclude a participant from the per-protocol population. Exploratory analyses will examine whether actigraphy-derived physical activity and light exposure are associated with, or modify, changes in the registered sleep, imaging, and cognitive outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60 years or older.
- •Subjective poor sleep for at least 3 months.
- •Pittsburgh Sleep Quality Index (PSQI) total score greater than
- •Willing and able to complete study assessments and the 6-week intervention.
- •Mini-Mental State Examination (MMSE) score of 24 or higher.
- •Provides written informed consent.
排除标准
- •Diagnosed dementia, Parkinson disease, or another progressive neurodegenerative disorder.
- •Stroke or severe head injury within the prior year.
- •Unstable major psychiatric illness.
- •AD8 score of 2 or higher or Geriatric Depression Scale (GDS) score of 5 or higher.
- •Severe sensory or comprehension problems that prevent study participation.
- •Night-shift work or frequent recent transmeridian travel.
- •Current CPAP or BiPAP use, or severe obstructive sleep apnea requiring immediate treatment, such as an apnea-hypopnea index greater than 30 with oxygen desaturation.
- •Use of 3 or more hypnotic medications with inability to maintain a stable dose.
- •Contraindication to magnetic resonance imaging.
- •Major neck surgery, neck radiation, or vascular anomaly that interferes with jugular ultrasonography.
- •Severe unstable systemic disease.
- •Severe coagulopathy or anticoagulation that makes acupuncture unsuitable.
- •Infection or wound at an acupuncture site.
- •Severe gait instability or inability to attend scheduled visits.
- •Any other condition that the investigator considers unsuitable for participation.
研究组 & 干预措施
Acupuncture
Participants receive a 6-week standardized acupuncture program.
干预措施: Acupuncture (Procedure)
结局指标
主要结局
Change in 7-day mean wake after sleep onset from baseline to Week 6
时间窗: Baseline and Week 6
Change equals the Week 6 mean minus the baseline mean. Wake after sleep onset (WASO) is the total minutes scored awake between sleep onset and final awakening for each valid night. Sleep is measured with Actiwatch 2 (Philips Respironics) worn on the nondominant wrist, recorded in 60-second epochs, and scored with Philips Actiware version 6.0.9 using sleep diaries. Each timepoint is the mean across all valid nights in the 7-day assessment window. A timepoint is valid if it includes at least 5 valid nights, including at least 1 weekend night; otherwise it is treated as missing. Unit: minutes.
次要结局
- Change in 7-day mean sleep efficiency from baseline to Week 6(Baseline and Week 6)
- Change in Pittsburgh Sleep Quality Index total score over time(Baseline, Week 6, and approximately 3 months after treatment)
- Change in 7-day mean number of awakenings from baseline to Week 6(Baseline and Week 6)
- Change in 7-day mean sleep fragmentation index from baseline to Week 6(Baseline and Week 6)
- Change in Insomnia Severity Index total score over time(Baseline, Weeks 2, 4, and 6, and approximately 3 months after treatment)
- Change in Epworth Sleepiness Scale total score over time(Baseline, Week 6, and approximately 3 months after treatment)
- Change in diffusion tensor imaging along the perivascular space index from baseline to Week 6(Baseline and Week 6)
- Change in side-specific internal jugular vein time-averaged mean blood-flow velocity from baseline to Week 6(Baseline and Week 6)
- Change in side-specific internal jugular vein cross-sectional area from baseline to Week 6(Baseline and Week 6)
研究者
Geng-Hao Liu
Principal Investigator
Chang Gung Memorial Hospital