The Effects of Lateralized Thermal Sleepwear on Sleep, Skin Temperature and Skin Moisture in Menopausal Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effects of Sleepwear With Lateralized Thermal Characteristics on Sleep, Proximal Skin Temperature and Sternal Skin Moisture in Menopausal Women

Conditions
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Menopause Related Conditions

Intervention / Treatment
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* Device: Sleepwear with Lateralized Thermal Characteristics
* Device: Sham-Lateralized Sleepwear


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 12 months since last menstrual period Subjective complaint of sleep disturbance, confirmed by Pittsburgh Sleep Quality Index score greater than 5 Subjective complaint of at least moderate symptoms of menopause, confirmed by modified Kupperman score greater than 15 Ability to sleep in the left lateral, right lateral and supine positions Exclusion Criteria: Unable to taper off, with health care provider's agreement, hypnotic or sedative medications, hormone replacement therapy, clonidine, gabapentin, or isoflavones and other botanical compounds used to treat vasomotor symptoms of menopause Unable to taper to two or fewer caffeinated beverages per day Unable to taper to one or fewer alcoholic beverages per day Unable to taper off nicotine in any form Unable to taper off recreational drugs Subjective sleep, based on two-week sleep logs, averaging less than 4.0 or greater than 7.5 hours per night Clinical suspicion of obstructive sleep apnea, periodic leg movements or other significant physiological sleep disturbance Known skin allergy to silver, cotton, nylon, surgical tape and other adhesives

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Hierarchical linear model evaluating repeated measures nested within subjects
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lateralized Thermal Sleepwear<br>For two consecutive nights subjects will wear Sleepwear with Lateralized Thermal Characteristics | Device: Sleepwear with Lateralized Thermal Characteristics<br>* Subjects will wear sleepwear constructed with insulating fabric on one side and conductive fabric on the other side, arranged bilaterally.<br>|
| Sham Comparator: Sham-Lateralized Sleepwear<br>For two consecutive nights subjects will wear Sham-Lateralized Sleepwear | Device: Sham-Lateralized Sleepwear<br>* Subjects will wear sleepwear constructed with two insulating fabrics arranged bilaterally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Sleep Time | Minutes of sleep of any stage, as scored by conventional criteria, across recording period. | 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. | 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. | Two nights in the experimental condition and two nights in the control condition. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proximal Skin Temperature | Thermochron iButton-derived measurements of skin temperature at bilateral Infraclavicular, Lateral Abdominal and Vastus Lateralis sites | Measurements taken every 90 seconds across two-night experimental and control conditions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin Temperature, Hot Flashes, Sleep Disturbance