Improving Sleep With the Far-infrared Emitting Pyjamas

NCT04890002 | Completed

• 1 other identifier: SFEP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Insomnia Severity Index (ISI)

  Baseline, week 2, week 4, and week 6

• The 7-day daily sleep diary

  Baseline and week 6

• Hospital Anxiety and Depression Scale (HADS)

  Baseline, week 2, week 4, and week 6

• Epworth Sleepiness Scale (ESS)

  Baseline, week 2, week 4, and week 6

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

  Baseline, week 2, week 4, and week 6

Study Arms (2)

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.

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.

Device: Sham-pyjamas

Interventions

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.

Far-infrared emitting pyjamas (FIR pyjamas) group

Sham-pyjamas DEVICE

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

Sham-pyjamas Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Wing Fai YEUNG

Hong Kong, 000000, Hong Kong

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Wing Fai YEUNG, Dortor

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 18, 2021
• Study Start: July 15, 2021
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: September 25, 2023

Record last verified: 2023-09

Locations

HK (1)