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

St. Peter's Hospital, Albany, NY

Status

Terminated

Conditions

Menopause Related Conditions

Treatments

Device: Sham-Lateralized Sleepwear

Device: Sleepwear with Lateralized Thermal Characteristics

Study type

Interventional

Funder types

Other

Identifiers

NCT03037554

Lateralized Thermal Sleepwear

Details and patient eligibility

About

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.

Full description

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.

Enrollment

4 patients

Sex

Female

Ages

40 to 69 years old

Volunteers

No Healthy Volunteers

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