Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000233123
Ethics application status
Approved
Date submitted
19/12/2018
Date registered
18/02/2019
Date last updated
26/09/2022
Date data sharing statement initially provided
18/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Sleepwear fibre and sleep quality in menopausal women
Scientific title
An Investigation of the Impact of Sleepwear Fibre Type on Menopausal Sleep Quality
Secondary ID [1] 296576 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep 310371 0
Menopausal symptoms 310372 0
Condition category
Condition code
Reproductive Health and Childbirth 309096 309096 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study employs a within-subject, randomised, repeated-measures design with natural fibre for different sleepwear types, with close matching of fabric thickness and mass per unit area. Following baseline assessments and a familiarisation night, each participant will be randomised to four polysomnography test nights (2 nights in sleepwearA and 2 in sleepwearB) with at least 24 hours separating each study trial.
Both sleepwear types are set in long sleeves and legs. The sleep laboratory will be maintained at 30C, 50% relative humidity.
Intervention code [1] 312886 0
Lifestyle
Intervention code [2] 313199 0
Prevention
Comparator / control treatment
Participants serve as their own control in a repeated-measures design.
Control group
Active

Outcomes
Primary outcome [1] 308065 0
A primary outcome is sleep quality (with composite variables of sleep onset latency, total sleep time, wake after sleep onset, sleep efficiency, sleep fragmentation index, percentage of sleep stages and EEG power density).
Timepoint [1] 308065 0
Each participant attends the Sleep laboratory on six occasions (over a 3-4 week period), a screening session and five overnight sleep studies (one familiarisation and four test nights). The sleep studies are separated by at least 24 hours.
Secondary outcome [1] 353855 0
Menopausal symptoms - the number of objective hot flashes recorded using the Bahr
Monitor.
Timepoint [1] 353855 0
The menopausal symptoms will be monitored on each night of the five overnight sleep studies.
Secondary outcome [2] 365180 0
Clothing comfort
Applying a composite scale of a) texture sensation; b) wetness perception; c) stickiness sensation; and d) pleasantness sensation (Raccuglia, M., Pistak, K., Heyde, C., Qu, J., Mao, N., Hodder, S., & Havenith, G. (2017). Human wetness perception of fabrics under dynamic skin contact. Textile Research Journal, 0040517517716905.)
Timepoint [2] 365180 0
The Clothing comfort scale will be administered at bedtime and on waking - on each of the four overnight sleep studies.
Secondary outcome [3] 365181 0
Mood using a visual analogue scale.
Timepoint [3] 365181 0
At bedtime - on each of the four overnight sleep studies.

Eligibility
Key inclusion criteria
•peri-menopausal (experience cyclic irregularity over the preceding 12 months and up
to 11 months of amenorrhea), or post-menopausal (have ceased menses for at least 1 year and not more than 2 years, or had bilateral oophorectomy at least six weeks before screening, and with Vasomotor scale of 2 or greater (Greene Climateric Scale) (Travers et al., 2005)
Minimum age
45 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
•Currently use medication containing estrogen, progestins, or androgens within 8 weeks from the start of the study.
•Have (or a history of) disorders that might affect sleep and/or thermoregulation (e.g., diabetes, cancer, heart disease, Raynaud's syndrome).
•Have (or a history of) moderate to severe sleep breathing disorders, sleep disorders and psychiatric conditions (e.g., insomnia, restless leg syndrome, depression, schizophrenia).
•Are on shift work or have crossed several time zones in the past fortnight.
•Are unwilling to refrain from moderate-intense exercise of greater than 30 minutes or mild exercise of greater than 1h on each sleep study night.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We use a randomization plan from http://www.randomization.com
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the trial the sample size was calculated using the G Power sample size calculator software and to analyse the findings the Analysis of variance (ANOVA).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/04/2019
Actual
21/01/2020
Date of last participant enrolment
Anticipated
30/11/2023
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
35
Accrual to date
32
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 301154 0
Commercial sector/Industry
Name [1] 301154 0
A sector of the clothing industry
Country [1] 301154 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 301743 0
None
Name [1] 301743 0
none
Address [1] 301743 0
none
Country [1] 301743 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301902 0
Sydney university Human Research Ethics Committee
Ethics committee address [1] 301902 0
Ethics committee country [1] 301902 0
Australia
Date submitted for ethics approval [1] 301902 0
10/02/2019
Approval date [1] 301902 0
17/04/2019
Ethics approval number [1] 301902 0
2020/PID03408
Ethics committee name [2] 309705 0
Sydney Local Health District Human Research Ethics Committee
Ethics committee address [2] 309705 0
Ethics committee country [2] 309705 0
Australia
Date submitted for ethics approval [2] 309705 0
12/11/2020
Approval date [2] 309705 0
22/01/2021
Ethics approval number [2] 309705 0
2020/PID03408

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88494 0
A/Prof Chin Moi Chow
Address 88494 0
Discipline of Exercise and Sport Science, The University of Sydney.
Susan Wakil Health Building, Western Ave, Camperdown NSW 2050.
Country 88494 0
Australia
Phone 88494 0
+61 2 9351 9332
Fax 88494 0
Email 88494 0
[email protected]
Contact person for public queries
Name 88495 0
Chin Moi Chow
Address 88495 0
Discipline of Exercise and Sport Science
The University of Sydney
75 East Street, Lidcombe, NSW 2141
Country 88495 0
Australia
Phone 88495 0
+61 2 9351 9332
Fax 88495 0
Email 88495 0
[email protected]
Contact person for scientific queries
Name 88496 0
Chin-Moi Chow
Address 88496 0
Discipline of Exercise and Sport Science
The University of Sydney
75 East Street, Lidcombe, NSW 2141
Country 88496 0
Australia
Phone 88496 0
+61 2 9351 9332
Fax 88496 0
Email 88496 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.