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 : April 12, 2019
|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, 2020|
|Estimated Study Completion Date :||March 15, 2020|
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.
- Total Sleep Time [ Time Frame: Two nights in the experimental condition and two 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: Two nights in the experimental condition and two 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: Two nights in the experimental condition and two 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 two-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 two nights in experimental condition and two nights in control condition ]Sleep position recorded by iPhone-based SomnoPose app
- Sternal Skin Moisture [ Time Frame: Measurements taken every three minutes across two nights in experimental condition and two nights in control condition ]Skin humidity at sternum recorded by specialized Thermochron iButton
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037554
|Contact: Kerry Hufland||518-464-9999||Kerry.Hufland@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|