NCT04890002

Improving Sleep With the Far-infrared Emitting Pyjamas

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Disorder

Interventions

Type	Name	Description
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.
DEVICE	Sham-pyjamas	The sham-pyjamas are made of pure cotton fibres and man-made fibres without the far-infrared emitting function.

Timeline

• Start date: 2021-07-15
• Primary completion: 2021-12-31
• Completion: 2022-03-31
• First posted: 2021-05-18
• Last updated: 2023-09-25

Locations

1 site across 1 country: Hong Kong