ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 8 of 153 for:    Recruiting, Not yet recruiting, Available Studies | menopause

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03037554
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Paul Glovinsky, Ph.D., St. Peter's Hospital, Albany, NY

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.

Condition or disease Intervention/treatment Phase
Menopause Related Conditions Device: Sleepwear with Lateralized Thermal Characteristics Device: Sham-Lateralized Sleepwear Not Applicable

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 six-night, home-based monitoring phases, one an experimental and one a control condition, separated by a washout period of at least two weeks. 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 and menopausal symptoms will also be employed.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Hierarchical linear model evaluating repeated measures nested within subjects
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.
Primary Purpose: Treatment
Official Title: The Effects of Sleepwear With Lateralized Thermal Characteristics on Sleep, Proximal Skin Temperature and Sternal Skin Moisture in Menopausal Women
Actual Study Start Date : May 21, 2017
Estimated Primary Completion Date : March 15, 2018
Estimated Study Completion Date : March 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
Experimental: Lateralized Thermal Sleepwear
For six 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 six consecutive nights subjects will wear Sham-Lateralized Sleepwear
Device: Sham-Lateralized Sleepwear
Subjects will wear sleepwear constructed with two insulating fabrics arranged bilaterally.




Primary Outcome Measures :
  1. Total Sleep Time [ Time Frame: Six nights in the experimental condition and six nights in the control condition. ]
    Minutes of sleep of any stage, as scored by conventional criteria, across recording period.

  2. Wakefulness After Sleep Onset [ Time Frame: Six nights in the experimental condition and six nights in the control condition. ]
    Minutes of Wakefulness, as scored by conventional criteria, from first epoch of sleep until end of recording period.

  3. Minutes of non-rapid eye movement (NREM) Stage 1 Sleep [ Time Frame: Six nights in the experimental condition and six nights in the control condition. ]
    Minutes of NREM Stage 1 Sleep, as scored by conventional criteria, across recording period.


Secondary Outcome Measures :
  1. Proximal Skin Temperature [ Time Frame: Measurements taken every 90 seconds across six-night experimental and control conditions ]
    Thermochron iButton-derived measurements of skin temperature at bilateral Infraclavicular, Lateral Abdominal and Vastus Lateralis sites


Other Outcome Measures:
  1. Position Monitoring [ Time Frame: Position sampled every two seconds across six nights in experimental condition and six nights in control condition ]
    Sleep position recorded by iPhone-based SomnoPose app

  2. Sternal Skin Moisture [ Time Frame: Measurements taken every three minutes across six nights in experimental condition and six nights in control condition ]
    Skin humidity at sternum recorded by specialized Thermochron iButton

  3. Subjective Insomnia Severity [ Time Frame: Weekly assessments during two week baseline period, six night experimental condition, two week washout period, six night control condition and two week follow up period ]
    Subjective sleep disturbance as measured by Insomnia Severity Index

  4. Menopausal Symptoms [ Time Frame: Weekly assessments during two week baseline period, six night experimental condition, two week washout period, six night control condition and two week follow up period ]
    Vasomotor and other symptoms of menopause and as measured by the modified Kupperman Scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 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 4.5 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037554


Contacts
Contact: Sarah Frisino 518-464-9999 Sarah.Frisino@sphp.com

Locations
United States, New York
St. Peter's Sleep Center Recruiting
Albany, New York, United States, 12205
Contact: Administrator    518-464-9999    sarah.frisino@sphp.com   
Sponsors and Collaborators
St. Peter's Hospital, Albany, NY
Investigators
Principal Investigator: Paul Glovinsky, Ph.D. St. Peter's Sleep Center

Responsible Party: Paul Glovinsky, Ph.D., Clinical Director, St. Peter's Sleep Center, St. Peter's Hospital, Albany, NY
ClinicalTrials.gov Identifier: NCT03037554     History of Changes
Other Study ID Numbers: Lateralized Thermal Sleepwear
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Paul Glovinsky, Ph.D., St. Peter's Hospital, Albany, NY:
Skin Temperature
Hot Flashes
Sleep Disturbance