The Effects of Lateralized Thermal Sleepwear on Sleep, Skin Temperature and Skin Moisture in Menopausal Women
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|ClinicalTrials.gov Identifier: NCT03037554|
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : December 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Menopause Related Conditions||Device: Sleepwear with Lateralized Thermal Characteristics Device: Sham-Lateralized Sleepwear||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|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.|
|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|
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.
- 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.
- 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.
- 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.
- 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
- 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
- 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
- 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
- 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
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
|Contact: Sarah Frisino||518-464-9999||Sarah.Frisino@sphp.com|
|United States, New York|
|St. Peter's Sleep Center||Recruiting|
|Albany, New York, United States, 12205|
|Contact: Administrator 518-464-9999 email@example.com|
|Principal Investigator:||Paul Glovinsky, Ph.D.||St. Peter's Sleep Center|