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

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

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.

Study Overview

• Status: Terminated
• Conditions: Menopause Related Conditions
• Intervention / Treatment: Device: Sleepwear with Lateralized Thermal Characteristics; Device: Sham-Lateralized Sleepwear

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12205
      • St. Peter's Sleep Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lateralized Thermal Sleepwear; For two consecutive nights subjects will wear Sleepwear with Lateralized Thermal Characteristics	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 Comparator: Sham-Lateralized Sleepwear; For two consecutive nights subjects will wear Sham-Lateralized Sleepwear	Device: Sham-Lateralized Sleepwear; Subjects will wear sleepwear constructed with two insulating fabrics arranged bilaterally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: St. Peter's Hospital, Albany, NY
• Investigators: Principal Investigator: Paul Glovinsky, Ph.D., St. Peter's Sleep Center

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2017
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): March 15, 2020

Study Registration Dates

• First Submitted: January 19, 2017
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (Estimate): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Sleep Disturbance; Hot Flashes; Skin Temperature
• Other Study ID Numbers: Lateralized Thermal Sleepwear

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No