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Completed

NCT Number: NCT04890002

Improving Sleep With the Far-infrared Emitting Pyjamas

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

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Key information

Conditions

Sleep Disorder Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wing Fai YEUNG

Hong Kong, 000000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Far-infrared emitting pyjamas

Device

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

Device

The sham-pyjamas are made of pure cotton fibres and man-made fibres without the far-infrared emitting function.

Primary outcomes

  1. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

Secondary outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: Baseline, week 2, week 4, and week 6

    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.

  2. The 7-day daily sleep diary

    Time frame: Baseline and week 6

    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).

  3. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline, week 2, week 4, and week 6

    The HADS is a 14-item self-administrated questionnaire, which assess the severity of depressive and anxiety symptoms

  4. Epworth Sleepiness Scale (ESS)

    Time frame: Baseline, week 2, week 4, and week 6

    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.

  5. The 5-item Satisfaction with Life Scale (SWLS)

    Time frame: Baseline, week 2, week 4, and week 6

    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.

  6. Multidimensional Fatigue Inventory (MFI)

    Time frame: Baseline, week 2, week 4, and week 6

    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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

Improving Sleep With the Far-infrared Emitting Pyjamas: A Pilot Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 18, 2021
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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