Sleep DisorderNCT04890002
Improving Sleep With the Far-infrared Emitting Pyjamas
A study testing Far-infrared emitting pyjamas in people with Sleep Disorder, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep Disorder
- What is being tested?
- Far-infrared emitting pyjamas
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Jul 2021to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Sleep With the Far-infrared Emitting Pyjamas: A Pilot Randomized Controlled Trial
The aim of this study is to explore the effects of a far-infrared emitting pyjamas on improving sleep in adults with poor sleep.
Read the detailed 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.
- Conditions
- Sleep Disorder
- Being tested
- Far-infrared emitting pyjamas, Sham-pyjamas
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Far-infrared emitting pyjamasDevice
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-pyjamasDevice
The sham-pyjamas are made of pure cotton fibres and man-made fibres without the far-infrared emitting function.
| Study group | Role | What they receive |
|---|---|---|
| Far-infrared emitting pyjamas (FIR pyjamas) group | Experimental | 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. Receives: Device: Far-infrared emitting pyjamas |
| Sham-pyjamas Group | Sham comparator | 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. Receives: Device: Sham-pyjamas |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week 2, week 4, and week 6
Secondary outcomes (6)
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.
Measured: Baseline, week 2, week 4, and week 6
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).
Measured: Baseline and week 6
Hospital Anxiety and Depression Scale (HADS)
The HADS is a 14-item self-administrated questionnaire, which assess the severity of depressive and anxiety symptoms
Measured: Baseline, week 2, week 4, and week 6
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.
Measured: Baseline, week 2, week 4, and week 6
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.
Measured: Baseline, week 2, week 4, and week 6
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.
Measured: Baseline, week 2, week 4, and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start15 Jul 2021
- Primary completion31 Dec 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YEUNG Wing Fai, The Hong Kong Polytechnic University
- Investigators
- Wing Fai YEUNG, Dortor, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890002
- Sponsor's protocol ID
- SFEP
- Status last verified
- Sep 2023
- First submitted
- 12 May 2021
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Sleep With the Far-infrared Emitting Pyjamas: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04890002
- Acronym / sponsor ID
- SFEP
- Conditions
- Sleep Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to explore the effects of a far-infrared emitting pyjamas on improving sleep in adults with poor sleep.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Far-infrared emitting pyjamas (FIR pyjamas) group | Experimental | Device: Far-infrared emitting pyjamasSubjects 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. |
| Sham-pyjamas Group | Sham comparator | Device: Sham-pyjamasTo 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Far-infrared emitting pyjamasClothing 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. | Device | Far-infrared emitting pyjamas (FIR pyjamas) group |
| Sham-pyjamasThe sham-pyjamas are made of pure cotton fibres and man-made fibres without the far-infrared emitting function. | Device | Sham-pyjamas Group |
Primary outcome
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.
6 secondary outcomes
Insomnia Severity Index (ISI)
Time frame: Baseline, week 2, week 4, and week 6
The 7-day daily sleep diary
Time frame: Baseline and week 6
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, week 2, week 4, and week 6
Epworth Sleepiness Scale (ESS)
Time frame: Baseline, week 2, week 4, and week 6
The 5-item Satisfaction with Life Scale (SWLS)
Time frame: Baseline, week 2, week 4, and week 6
Multidimensional Fatigue Inventory (MFI)
Time frame: Baseline, week 2, week 4, and week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wing Fai YEUNG, Dortor principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Far-infrared emitting pyjamas in people with Sleep Disorder, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI) (time frame: Baseline, week 2, week 4, and week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.