Clinical trial NCT04890002: Improving Sleep With the Far-infrared Emitting Pyjamas
Official title: Improving Sleep With the Far-infrared Emitting Pyjamas: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorder
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, week 2, week 4, and week 6
Secondary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline, week 2, week 4, and week 6
measure: The 7-day daily sleep diary
timeFrame: Baseline and week 6
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, week 2, week 4, and week 6
measure: Epworth Sleepiness Scale (ESS)
timeFrame: Baseline, week 2, week 4, and week 6
measure: The 5-item Satisfaction with Life Scale (SWLS)
timeFrame: Baseline, week 2, week 4, and week 6
measure: Multidimensional Fatigue Inventory (MFI)
timeFrame: Baseline, week 2, week 4, and week 6
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Wing Fai YEUNG
Study officials:
affiliation: Hong Kong Polytechnic University
name: Wing Fai YEUNG, Dortor
role: PRINCIPAL_INVESTIGATOR
References: