None listed
Conditions
Brief summary
This study compares the sleep outcomes (sleep quality) between two different sleepwear type (closely matched for fabric thickness and weight) in peri- and post-menopausal women. It is hypothesised that sleepwearA provides beneficial measured sleep outcomes (sleep quality and quantity, and sleep encephalograph power density) over sleepwearB.
Interventions
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
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.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to 65 Years
Healthy volunteers
No
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.
Outcome results
None listed