A home-based, sham-controlled, double-blind, crossover study evaluating the effects of wearing sleepwear with lateralized thermal characteristics on subjective and objective sleep measures, proximal skin temperature, and sternal skin moisture in menopausal women complaining of sleep disturbance and vasomotor symptoms.
Sixteen menopausal women who have given informed consent to participate will be medically screened to rule out physiological sleep disorders. Sleep schedules will be regulated to the average bedtime of a two-week baseline sleep log. Subjects will undergo two two-night, home-based monitoring phases, one an experimental and one a control condition, separated by a washout period of at least five nights. The order of conditions will be counterbalanced between subjects in double-blind fashion. In the experimental condition subjects will wear sleepwear constructed of two fabric types arranged bilaterally, with typical cotton spandex insulating material on one side and specialized conductive material on the other. In the control condition subjects will wear sleepwear that is similarly lateralized in terms of appearance but constructed with typical cotton spandex insulating material on both sides. Ambulatory monitoring will include body position, EEG, actigraphy, skin temperature at multiple proximal sites, and sternal skin moisture. Subjective scales of insomnia severity, menopausal symptoms and sleepwear rating will also be employed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
4
Subjects will wear sleepwear constructed with insulating fabric on one side and conductive fabric on the other side, arranged bilaterally.
Subjects will wear sleepwear constructed with two insulating fabrics arranged bilaterally.
St. Peter's Sleep Center
Albany, New York, United States
Total Sleep Time
Minutes of sleep of any stage, as scored by conventional criteria, across recording period.
Time frame: Two nights in the experimental condition and two nights in the control condition.
Wakefulness After Sleep Onset
Minutes of Wakefulness, as scored by conventional criteria, from first epoch of sleep until end of recording period.
Time frame: Two nights in the experimental condition and two nights in the control condition.
Minutes of non-rapid eye movement (NREM) Stage 1 Sleep
Minutes of NREM Stage 1 Sleep, as scored by conventional criteria, across recording period.
Time frame: Two nights in the experimental condition and two nights in the control condition.
Proximal Skin Temperature
Thermochron iButton-derived measurements of skin temperature at bilateral Infraclavicular, Lateral Abdominal and Vastus Lateralis sites
Time frame: Measurements taken every 90 seconds across two-night experimental and control conditions
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