Menopause Related ConditionsNCT03037554
The Effects of Lateralized Thermal Sleepwear on Sleep, Skin Temperature and Skin Moisture in Menopausal Women
A study testing Sleepwear with Lateralized Thermal Characteristics in people with Menopause Related Conditions, run by St. Peter's Hospital, Albany, NY at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 69 years, women only
- Conditions the study is for
- Menopause Related Conditions
- What is being tested?
- Sleepwear with Lateralized Thermal Characteristics
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2017to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Menopause Related Conditions
- Being tested
- Sleepwear with Lateralized Thermal Characteristics, Sham-Lateralized Sleepwear
- Keywords
- Skin Temperature, Hot Flashes, Sleep Disturbance
- Medical subject headings
- Hot Flashes, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleepwear with Lateralized Thermal CharacteristicsDevice
Subjects will wear sleepwear constructed with insulating fabric on one side and conductive fabric on the other side, arranged bilaterally.
Sham-Lateralized SleepwearDevice
Subjects will wear sleepwear constructed with two insulating fabrics arranged bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| Lateralized Thermal Sleepwear | Experimental | For two consecutive nights subjects will wear Sleepwear with Lateralized Thermal Characteristics Receives: Device: Sleepwear with Lateralized Thermal Characteristics |
| Sham-Lateralized Sleepwear | Sham comparator | For two consecutive nights subjects will wear Sham-Lateralized Sleepwear Receives: Device: Sham-Lateralized Sleepwear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time
Minutes of sleep of any stage, as scored by conventional criteria, across recording period.
Measured: 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.
Measured: 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.
Measured: Two nights in the experimental condition and two nights in the control condition.
Secondary outcomes (1)
Proximal Skin Temperature
Thermochron iButton-derived measurements of skin temperature at bilateral Infraclavicular, Lateral Abdominal and Vastus Lateralis sites
Measured: Measurements taken every 90 seconds across two-night experimental and control conditions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start21 May 2017
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Why it stopped: Technical difficulties with ambulatory equipment led to unacceptably high levels of data loss. As we would have had to suspend data collection under Covid precautions in any case, we decided to terminate in March of this year.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopause Related ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Hierarchical linear model evaluating repeated measures nested within subjects
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Peter's Hospital, Albany, NY
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Glovinsky, Ph.D., St. Peter's Hospital, Albany, NY
- Investigators
- Paul Glovinsky, Ph.D., Principal investigator, St. Peter's Sleep Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037554
- Sponsor's protocol ID
- Lateralized Thermal Sleepwear
- Status last verified
- Mar 2021
- First submitted
- 19 Jan 2017
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sleepwear With Lateralized Thermal Characteristics on Sleep, Proximal Skin Temperature and Sternal Skin Moisture in Menopausal Women
- ClinicalTrials.gov ID
- NCT03037554
- Acronym / sponsor ID
- Lateralized Thermal Sleepwear
- Conditions
- Menopause Related Conditions
- Keywords
- Skin Temperature, Hot Flashes, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Technical difficulties with ambulatory equipment led to unacceptably high levels of data loss. As we would have had to suspend data collection under Covid precautions in any case, we decided to terminate in March of this year.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- St. Peter's Hospital, Albany, NYUniversity, hospital or other
- Study start
- 21 May 2017 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Hierarchical linear model evaluating repeated measures nested within subjects
| Arm | Type | Receives |
|---|---|---|
| Lateralized Thermal Sleepwear | Experimental | Device: Sleepwear with Lateralized Thermal CharacteristicsFor two consecutive nights subjects will wear Sleepwear with Lateralized Thermal Characteristics |
| Sham-Lateralized Sleepwear | Sham comparator | Device: Sham-Lateralized SleepwearFor two consecutive nights subjects will wear Sham-Lateralized Sleepwear |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleepwear with Lateralized Thermal CharacteristicsSubjects will wear sleepwear constructed with insulating fabric on one side and conductive fabric on the other side, arranged bilaterally. | Device | Lateralized Thermal Sleepwear |
| Sham-Lateralized SleepwearSubjects will wear sleepwear constructed with two insulating fabrics arranged bilaterally. | Device | Sham-Lateralized Sleepwear |
Primary outcome
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.
1 secondary outcome
Proximal Skin Temperature
Time frame: Measurements taken every 90 seconds across two-night experimental and control conditions
Results and safety
The study was stopped early (reason given: Technical difficulties with ambulatory equipment led to unacceptably high levels of data loss. As we would have had to suspend data collection under Covid precautions in any case, we decided to terminate in March of this year.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Glovinsky, Ph.D. principal investigator
St. Peter's Sleep Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleepwear with Lateralized Thermal Characteristics in people with Menopause Related Conditions, run by St. Peter's Hospital, Albany, NY at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Technical difficulties with ambulatory equipment led to unacceptably high levels of data loss. As we would have had to suspend data collection under Covid precautions in any case, we decided to terminate in March of this year.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Sleep Time (time frame: Two nights in the experimental condition and two nights in the control condition.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.