Sleepwear fibre and sleep quality in menopausal wome

Not Applicable

Recruiting

• Conditions: Sleep; Menopausal symptoms; Reproductive Health and Childbirth - Menstruation and menopause

• Registration Number: ACTRN12619000233123
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-18
• Last Update Posted: 3 October 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 35

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)

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).[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. <br>]

Secondary Outcome Measures

Name	Time	Method
Menopausal symptoms - the number of objective hot flashes recorded using the Bahr <br>Monitor.[The menopausal symptoms will be monitored on each night of the five overnight sleep studies.];Clothing comfort <br>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.)[The Clothing comfort scale will be administered at bedtime and on waking - on each of the four overnight sleep studies.];Mood using a visual analogue scale.[At bedtime - on each of the four overnight sleep studies.]