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

NCT03037554 | Terminated

• 1 other identifier: Lateralized Thermal Sleepwear
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause Related Conditions

Keywords

Skin Temperature; Hot Flashes; Sleep Disturbance

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Proximal Skin Temperature

  Measurements taken every 90 seconds across two-night experimental and control conditions

Other Outcomes (2)

• Position Monitoring

  Position sampled every two seconds across two nights in experimental condition and two nights in control condition

• Sternal Skin Moisture

  Measurements taken every three minutes across two nights in experimental condition and two nights in control condition

Study Arms (2)

Lateralized Thermal Sleepwear

EXPERIMENTAL

For two consecutive nights subjects will wear Sleepwear with Lateralized Thermal Characteristics

Device: Sleepwear with Lateralized Thermal Characteristics

Sham-Lateralized Sleepwear

SHAM COMPARATOR

For two consecutive nights subjects will wear Sham-Lateralized Sleepwear

Device: Sham-Lateralized Sleepwear

Interventions

Sleepwear with Lateralized Thermal Characteristics DEVICE

Subjects will wear sleepwear constructed with insulating fabric on one side and conductive fabric on the other side, arranged bilaterally.

Lateralized Thermal Sleepwear

Sham-Lateralized Sleepwear DEVICE

Subjects will wear sleepwear constructed with two insulating fabrics arranged bilaterally.

Sham-Lateralized Sleepwear

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Peter's Hospital, Albany, NY: lead

Study Sites (1)

St. Peter's Sleep Center

Albany, New York, 12205, United States

Location

MeSH Terms

Conditions

Hot Flashes; Parasomnias

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Paul Glovinsky, Ph.D.

  St. Peter's Sleep Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director, St. Peter's Sleep Center

Model Details: Hierarchical linear model evaluating repeated measures nested within subjects

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 31, 2017
• Study Start: May 21, 2017
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)