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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-21

Study Completion Date

2020-03-15

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.

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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.

Conditions

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Menopause Related Conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Hierarchical linear model evaluating repeated measures nested within subjects

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Treatment and sham-control sleepwear will be allocated to subjects in a counterbalanced manner by a study administrator who will not otherwise interact with subjects.

Study Groups

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Lateralized Thermal Sleepwear

For two consecutive nights subjects will wear Sleepwear with Lateralized Thermal Characteristics

Group Type EXPERIMENTAL

Sleepwear with Lateralized Thermal Characteristics

Intervention Type DEVICE

Subjects will wear sleepwear constructed with insulating fabric on one side and conductive fabric on the other side, arranged bilaterally.

Sham-Lateralized Sleepwear

For two consecutive nights subjects will wear Sham-Lateralized Sleepwear

Group Type SHAM_COMPARATOR

Sham-Lateralized Sleepwear

Intervention Type DEVICE

Subjects will wear sleepwear constructed with two insulating fabrics arranged bilaterally.

Interventions

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Sleepwear with Lateralized Thermal Characteristics

Subjects will wear sleepwear constructed with insulating fabric on one side and conductive fabric on the other side, arranged bilaterally.

Intervention Type DEVICE

Sham-Lateralized Sleepwear

Subjects will wear sleepwear constructed with two insulating fabrics arranged bilaterally.

Intervention Type DEVICE

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

69 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No