Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04890002
Status:
COMPLETED
Last Update Posted:
2023-09-25
First Post:
2021-05-12
Brief Title:
Improving Sleep With the Far-infrared Emitting Pyjamas
Sponsor:
The Hong Kong Polytechnic University
Organization:
The Hong Kong Polytechnic University
Study Overview
Official Title:
Improving Sleep With the Far-infrared Emitting Pyjamas A Pilot Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None