Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04890002
Other study ID # SFEP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 15, 2021
Est. completion date March 31, 2022

Study information

Verified date September 2023
Source The Hong Kong Polytechnic University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to explore the effects of a far-infrared emitting pyjamas on improving sleep in adults with poor sleep.


Description:

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. Data Analysis: Differences in the questionnaire scores, subjective sleep parameters will be examined using a mixed-effects model. Clinical significance of sleep improvement between two groups will be compared with chi-squared test.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Far-infrared emitting pyjamas
Clothing made in far infrared (FIR) - based textiles could be a sustainable way for alleviating sleep problems with many advantages. Firstly, the proposed far infrared textiles are made of man-made profiled fibers without the addition of chemicals such as ceramic additives or other related coatings.
Sham-pyjamas
The sham-pyjamas are made of pure cotton fibres and man-made fibres without the far-infrared emitting function.

Locations

Country Name City State
Hong Kong Wing Fai YEUNG Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pittsburgh Sleep Quality Index (PSQI) 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. Baseline, week 2, week 4, and week 6
Secondary Insomnia Severity Index (ISI) The ISI is a seven-item self-rating scale. The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia on a 5-point Likert scale. The ISI is a validated instrument which has been commonly used in clinical trials of insomnia. Baseline, week 2, week 4, and week 6
Secondary The 7-day daily sleep diary The standardized sleep diary records the bedtime and rising time, from which the total time in bed (TIB) can be calculated. Subjects will be asked to estimate sleep-onset latency, wake after sleep onset, and total sleep time (TST). They will also rate their sleep quality on a 4-point scale (very good, fairly good, fairly bad, and very bad). Baseline and week 6
Secondary Hospital Anxiety and Depression Scale (HADS) The HADS is a 14-item self-administrated questionnaire, which assess the severity of depressive and anxiety symptoms Baseline, week 2, week 4, and week 6
Secondary Epworth Sleepiness Scale (ESS) The ESS is a self-rated questionnaire assessing the level of daytime sleepiness in eight common daily activities. The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'. The questionnaire takes no more than 2 or 3 minutes to answer. Baseline, week 2, week 4, and week 6
Secondary The 5-item Satisfaction with Life Scale (SWLS) The score of SWLS is found to predict mental health which has been used for assessing subjective well-being of subjects with health conditions. Scores consist of a raw score (between 5 and 35). Higher scores represent higher life satisfaction. Scorers can be assigned into six well-being categories and interpretative text in provided for each. Baseline, week 2, week 4, and week 6
Secondary Multidimensional Fatigue Inventory (MFI) MFI is a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. In an initial psychometric evaluation, developers reported an internal consistency ranging from .53 to .93. The scale was also found to be sensitive to differences between the participant groups. Baseline, week 2, week 4, and week 6
See also
  Status Clinical Trial Phase
Recruiting NCT05820919 - Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase N/A
Recruiting NCT04786314 - The Effect of Hot and Cold Water Application on Pregnant Women With Restless Leg Syndrome N/A
Recruiting NCT05775731 - Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
Recruiting NCT03326765 - Characterizing Sleep Disorders in Children and Adults With Tuberous Sclerosis Complex (TSC) N/A
Completed NCT03673397 - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression N/A
Completed NCT03903263 - Sleep Disturbances in Dermatology Patients
Not yet recruiting NCT06012513 - Sleep Disorders and Quality of Life in Patients With Multiple Sclerosis
Not yet recruiting NCT05950932 - Effects of Melissa Extract on Sleep Characteristics Phase 4
Completed NCT01463839 - Sleep Disorder and Oral Habits in Children N/A
Completed NCT00940589 - Efficacy of Circadin® 2 mg in Patients With Mild to Moderate Alzheimer Disease Treated With AChE Inhibitor Phase 2
Recruiting NCT06093633 - A Prospective Study to Evaluate the WP in Comparison to PSG in Patients Suspected of Sleep Disorders
Completed NCT06108115 - Smartphone-Based Intervention for Sleep Disturbance in Individuals Recovering From Alcohol Use Disorder N/A
Completed NCT05511818 - Radicle Rest: A Study of Cannabinoids on Sleep and Health Outcomes N/A
Active, not recruiting NCT04291014 - Light Therapy for PD - Dose Selection N/A
Completed NCT04560595 - Remote Guided Caffeine Reduction N/A
Completed NCT06008470 - Investigation of Respiratory Muscle Strength, Exercise Capacity, Physical Activity and Sleep Quality Level in Individuals With Covid-19 Infection
Recruiting NCT06129942 - Light Therapy in Parkinson's Disease N/A
Recruiting NCT04318067 - Melatonin in ADHD and Sleep Problems Phase 4
Completed NCT03532269 - Validation of the Sleep Assessment Algorithm in the Medical Application Nightly N/A
Completed NCT03857802 - Efficiency of a Nursing Intervention in Sleep Hygiene N/A