Improving Sleep With the Far-infrared Emitting Pyjamas: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
The aim of this study is to explore the effects of a far-infrared emitting pyjamas on improving sleep in adults with poor sleep.
详细描述
Objectives: To explore the effects of a far-infrared emitting pyjamas on improving sleep in adults with poor sleep.
Hypothesis: Subjects who wear the far-infrared emitting pyjamas (FIR pyjamas) will have greater improvement in sleep quality than the subjects in sham pyjamas control group (sham-pyjamas) at 2, 4 and 6 weeks.
Design and subjects: A pilot randomized sham-controlled trial. Subjects with subjective sleep complaints will be recruited from the community. 40 subjects will be randomized to far-infrared emitting pyjamas and sham-pyjamas groups in a 1: 1 ratio. Study instrument: Pittsburgh Sleep Quality Index (PSQI) will be used as an overall evaluation of sleep quality.
Interventions: Subjects in the FIR pyjamas group will received pyjamas with far-infrared emitting features and will wear it every night for 6 weeks; subjects in the sham-pyjamas group will receive pyjamas in identical appearance without far-infrared emitting features.
Outcome measures: The primary outcome measure is the PSQI score. Other measures include insomnia severity index (ISI), sleep parameters derived from 7-day sleep diary, Hospital Anxiety and Depression Scale (HADS), Epworth Sleepiness Scale (ESS) and Satisfaction With Life Scale (SWLS) at 2, 4 and 6 weeks. Acceptability of the far-infrared emitting pyjamas will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese Hong Kong residents who are able to read Chinese;
- •Aged 18 - 65 years;
- •Subjective sleep complaints of having difficulties in falling asleep, difficulties in staying asleep, or early morning awakening with consequences for daily life for at least 3 months.
- •Pittsburgh Sleep Quality Index total score of at least 5 indicating sleep disturbance with 89.6% sensitivity and 86.5% specificity; and
- •Willing to give informed consent and comply with the trial protocol.
排除标准
- •Currently receiving psychotherapy or participating in other clinical trials for insomnia;
- •Pregnancy;
- •Shift workers;
- •At significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (score ≥ 3);
- •No comorbid sleep disorders primarily requiring other treatment, such as sleep apnea or narcolepsy; and
- •Taking herbal remedies, over-the-counter medication, or psychotropic drugs that target insomnia within the 2 weeks prior to baseline.
研究组 & 干预措施
Far-infrared emitting pyjamas (FIR pyjamas) group
Subjects in this group will be provided the Far-infrared emitting pyjamas. The FIR pyjamas was fabricated by using two textile materials, pure cotton fibres and the proposed man-made FIR fibres with the far-infrared emitting function.
干预措施: Far-infrared emitting pyjamas (Device)
Sham-pyjamas Group
To control the placebo effect in the FIR pyjamas group, participants in this group will receive pyjamas with identical physical appearance which are produced using the same fabrication process as the pyjamas received in FIR pyjamas group. The sham-pyjamas are made of pure cotton fibres and man-made fibres without the far-infrared emitting function. The participants will be asked to wear the sham-pyjamas daily at night for 6 consecutive weeks.
干预措施: Sham-pyjamas (Device)
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI)
时间窗: Baseline, week 2, week 4, and week 6
The PSQI is a self-reported evaluation of the overall sleep quality. Subjects will be asked to report the sleep parameters of their sleep problem, use of sleep medicine, disturbance, and daytime dysfunction with 0-3 rating. The time frame of PSQI adopted in this study will be changed from "past 1 month" to "past 2 weeks". The PSQI is a reliable and validated tool widely used in sleep studies.
次要结局
- Epworth Sleepiness Scale (ESS)(Baseline, week 2, week 4, and week 6)
- The 5-item Satisfaction with Life Scale (SWLS)(Baseline, week 2, week 4, and week 6)
- Insomnia Severity Index (ISI)(Baseline, week 2, week 4, and week 6)
- The 7-day daily sleep diary(Baseline and week 6)
- Hospital Anxiety and Depression Scale (HADS)(Baseline, week 2, week 4, and week 6)
- Multidimensional Fatigue Inventory (MFI)(Baseline, week 2, week 4, and week 6)
研究者
YEUNG Wing Fai
Dr
The Hong Kong Polytechnic University