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

Stopped early · Not applicable · Has a placebo group

Conditions studied: Menopause Related Conditions

In brief

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.

Key facts

Study ID

NCT03037554

Run by

St. Peter's Hospital, Albany, NY

People needed

4

Starts

2017-05-21

Expected to finish

2020-03-15

Last updated by the study team

2021-04-01

Who can join

Age: 40 and older, up to 69. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• St. Peter's Sleep Center — Albany, New York, United States

Full record on ClinicalTrials.gov

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