Menopause Related Conditions
Conditions
Keywords
Skin Temperature, Hot Flashes, Sleep Disturbance
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.
Interventions
DEVICESleepwear with Lateralized Thermal Characteristics
Subjects will wear sleepwear constructed with insulating fabric on one side and conductive fabric on the other side, arranged bilaterally.
DEVICESham-Lateralized Sleepwear
Subjects will wear sleepwear constructed with two insulating fabrics arranged bilaterally.
Sponsors
St. Peter's Hospital, Albany, NY
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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.
Intervention model description
Hierarchical linear model evaluating repeated measures nested within subjects
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 69 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Sleep Time | 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 | 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. |
| Minutes of non-rapid eye movement (NREM) Stage 1 Sleep | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proximal Skin Temperature | Measurements taken every 90 seconds across two-night experimental and control conditions | Thermochron iButton-derived measurements of skin temperature at bilateral Infraclavicular, Lateral Abdominal and Vastus Lateralis sites |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sternal Skin Moisture | Measurements taken every three minutes across two nights in experimental condition and two nights in control condition | Skin humidity at sternum recorded by specialized Thermochron iButton |
| Position Monitoring | Position sampled every two seconds across two nights in experimental condition and two nights in control condition | Sleep position recorded by iPhone-based SomnoPose app |
Countries
United States
Outcome results
None listed