The Effects of Sleepwear With Lateralized Thermal Characteristics on Sleep, Proximal Skin Temperature and Sternal Skin Moisture in Menopausal Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Minutes of non-rapid eye movement (NREM) Stage 1 Sleep
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
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.
Eligibility Criteria
- Ages
- 40 Years to 69 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Lateralized Thermal Sleepwear
For two consecutive nights subjects will wear Sleepwear with Lateralized Thermal Characteristics
Intervention: Sleepwear with Lateralized Thermal Characteristics (Device)
Sham-Lateralized Sleepwear
For two consecutive nights subjects will wear Sham-Lateralized Sleepwear
Intervention: Sham-Lateralized Sleepwear (Device)
Outcomes
Primary Outcomes
Minutes of non-rapid eye movement (NREM) Stage 1 Sleep
Time Frame: Two nights in the experimental condition and two nights in the control condition.
Minutes of NREM Stage 1 Sleep, as scored by conventional criteria, across recording period.
Total Sleep Time
Time Frame: Two nights in the experimental condition and two nights in the control condition.
Minutes of sleep of any stage, as scored by conventional criteria, across recording period.
Wakefulness After Sleep Onset
Time Frame: Two nights in the experimental condition and two nights in the control condition.
Minutes of Wakefulness, as scored by conventional criteria, from first epoch of sleep until end of recording period.
Secondary Outcomes
- Proximal Skin Temperature(Measurements taken every 90 seconds across two-night experimental and control conditions)
Investigators
Paul Glovinsky, Ph.D.
Clinical Director, St. Peter's Sleep Center
St. Peter's Hospital, Albany, NY