Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2025-08-13
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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DistaSense and Polysomnography
All subjects will be evaluated by DistaSense and reference device for respiratory rate and heart rate.
Eligibility Criteria
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Inclusion Criteria
2. Fluent in English
3. Willing and cognitively able to provide informed consent
4. BMI \< 36
5. Expected by the investigator to achieve sufficient sleep duration for a minimum of 4 hours of meaningful data (e.g., absence of significant insomnia)
6. Able to complete the scripted portion of the evaluation
Exclusion Criteria
2. Sufficiently broken, damaged or irritated skin or rashes near the sensor application sites such that investigator believes should be precluded from enrollment
3. Subjects with electronic implants of any kind (e.g. pacemaker)
4. Subjects that are Life Detection Technology employees or shareholders, or family of a Life Detection Technology employee or shareholder
22 Years
ALL
Yes
Sponsors
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Nilo Medical Consulting Group
UNKNOWN
Life Detection Technologies
INDUSTRY
Responsible Party
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Locations
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Clayton Sleep Institute
St Louis, Missouri, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Countries
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Facility Contacts
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Chief Operating Officer; Co-Director CSI Research Center
Role: primary
Other Identifiers
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TP-25-002
Identifier Type: -
Identifier Source: org_study_id
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