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

Menopause Related Conditions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03037554
• Other study ID #: Lateralized Thermal Sleepwear
• Status: Terminated
• Phase: N/A
• Start date: May 21, 2017
• Est. completion date: March 15, 2020

Study information

• Verified date: March 2021
• Source: St. Peter's Hospital, Albany, NY
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopause Related Conditions

Intervention

Device:
• Sleepwear with Lateralized Thermal Characteristics
Subjects will wear sleepwear constructed with insulating fabric on one side and conductive fabric on the other side, arranged bilaterally.
• Sham-Lateralized Sleepwear
Subjects will wear sleepwear constructed with two insulating fabrics arranged bilaterally.

Locations

Country	Name	City	State
United States	St. Peter's Sleep Center	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
St. Peter's Hospital, Albany, NY

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Position Monitoring	Sleep position recorded by iPhone-based SomnoPose app	Position sampled every two seconds across two nights in experimental condition and two nights in control condition
Other	Sternal Skin Moisture	Skin humidity at sternum recorded by specialized Thermochron iButton	Measurements taken every three minutes across two nights in experimental condition and two nights in control condition
Primary	Total Sleep Time	Minutes of sleep of any stage, as scored by conventional criteria, across recording period.	Two nights in the experimental condition and two nights in the control condition.
Primary	Wakefulness After Sleep Onset	Minutes of Wakefulness, as scored by conventional criteria, from first epoch of sleep until end of recording period.	Two nights in the experimental condition and two nights in the control condition.
Primary	Minutes of non-rapid eye movement (NREM) Stage 1 Sleep	Minutes of NREM Stage 1 Sleep, as scored by conventional criteria, across recording period.	Two nights in the experimental condition and two nights in the control condition.
Secondary	Proximal Skin Temperature	Thermochron iButton-derived measurements of skin temperature at bilateral Infraclavicular, Lateral Abdominal and Vastus Lateralis sites	Measurements taken every 90 seconds across two-night experimental and control conditions