Clinical trial NCT03037554: The Effects of Lateralized Thermal Sleepwear on Sleep, Skin Temperature and Skin Moisture in Menopausal Women
Official title: The Effects of Sleepwear With Lateralized Thermal Characteristics on Sleep, Proximal Skin Temperature and Sternal Skin Moisture in Menopausal Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Menopause Related Conditions
Keywords: Skin Temperature
Hot Flashes
Sleep Disturbance
Lead sponsor: St. Peter's Hospital, Albany, NY
Sponsor class: OTHER
First posted: 2017-01-31
Enrollment: 4
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Hierarchical linear model evaluating repeated measures nested within subjects
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Sleep Time
timeFrame: Two nights in the experimental condition and two nights in the control condition.
measure: Wakefulness After Sleep Onset
timeFrame: Two nights in the experimental condition and two nights in the control condition.
measure: Minutes of non-rapid eye movement (NREM) Stage 1 Sleep
timeFrame: Two nights in the experimental condition and two nights in the control condition.
Secondary outcomes:
measure: Proximal Skin Temperature
timeFrame: Measurements taken every 90 seconds across two-night experimental and control conditions
Other outcomes:
measure: Position Monitoring
timeFrame: Position sampled every two seconds across two nights in experimental condition and two nights in control condition
measure: Sternal Skin Moisture
timeFrame: Measurements taken every three minutes across two nights in experimental condition and two nights in control condition
Locations:
city: Albany
country: United States
facility: St. Peter's Sleep Center
state: New York
Study officials:
affiliation: St. Peter's Sleep Center
name: Paul Glovinsky, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: