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

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 six-night,
home-based monitoring phases, one an experimental and one a control condition, separated by a
washout period of at least two weeks. 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 and menopausal
symptoms will also be employed.

Inclusion Criteria:

- At least 18 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 4.5 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