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Validation of Non-invasive Miniature Optical Sensors for Scoring Sleep Stages

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ClinicalTrials.gov Identifier: NCT03823105
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : February 1, 2019
Sponsor:
Collaborators:
University of Bern
CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Tracking Information
First Submitted Date  ICMJE January 29, 2019
First Posted Date  ICMJE January 30, 2019
Last Update Posted Date February 1, 2019
Actual Study Start Date  ICMJE December 6, 2018
Estimated Primary Completion Date May 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
  • Total Sleep Time (TST) and sleep architecture (distribution of sleep stages) [ Time Frame: 1 night ]
    Diagnostic accuracy of the new algorithm compared to the Gold Standard full polysomnography
  • The total time in non-REM sleep (stages 1-3), REM sleep, and awake after sleep onset [ Time Frame: 1 night ]
    Diagnostic accuracy of the new algorithm compared to the Gold Standard full polysomnography
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03823105 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Validation of Non-invasive Miniature Optical Sensors for Scoring Sleep Stages
Official Title  ICMJE Validation of Non-invasive Miniature Optical Sensors for Scoring Sleep Stages: a Prospective, Method-comparison, Proof of Concept, Single-centre Phase IV Study
Brief Summary Validation of two devices with optical sensor in healthy participants and patients with sleep wake disorders.
Detailed Description The objective of this study is to evaluate and optimize a method of detecting sleep and sleep stages based on a new algorithm combining actigraphy and heart rate variability (measured by optical analysis of the pulse wave) to determine sleep architecture (segmented into three phases: WAKE, REM and NREM) with high accuracy compared to the gold standard polysomnography.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Sleep-Wake Disorders
  • Healthy
Intervention  ICMJE Device: OHR Tracker and PulseWatch
Category A (ClinO). Medical study with CE-marked medical devices to photoplethysmographic measure heart rate, heart rate variability, and pulse wave and accelometric data
Study Arms  ICMJE Experimental: Nocturnal Recording
Recording of photoplethysmographic pulse wave and accelometry with two devices (OHR Tracker, PulseWatch) in parallel to the standard polysomnography
Intervention: Device: OHR Tracker and PulseWatch
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 29, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date May 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Patients with sleep wake disorders

Inclusion Criteria:

  • 18 ≤ Age ≤ 80 years
  • Suspected sleep wake disorder (sleep apnea, sleep movement disorders, hypersomnia, parasomnia)
  • Written informed consent

Exclusion Criteria:

  • Skin condition with eczema or damaged skin
  • Ischemia (cutaneous)
  • Allergy against nickel
  • Allergy against silicone
  • Current treatment with vasoactive drugs (e.g. beta-blockers, calcium channel antagonists, nitroglycerin, etc.) and/or antidepressive drugs (e.g. serotonin reuptake inhibitors, etc.).
  • Known infection with multiresistant bacteria
  • Implanted devices (e.g. pacemaker, pumps)
  • Rhythmogenic heart disease (e.g. resting heart rate > 120/min)
  • Severe or untreated arterial hypertension (blood pressure > 140mmHg systolic, >90mmHg diastolic)
  • Hypotension (blood pressure < 90mmHg systolic, < 60 mmHg diastolic)
  • Current alcohol or drug abuse, alcohol consumption the same day as the study
  • Consumption of coffee 7h before
  • Dark skin pigmentation
  • Severe metabolic disease (e.g. diabetes)
  • Pregnancy or lactation
  • Physical handicap effecting the two arms
  • Wound in the wrist region
  • Too large or too small wrist

Healthy subjects

Inclusion criteria:

  • 18 ≤ Age ≤ 80 years
  • Written informed consent

Exclusion criteria:

  • Skin condition with eczema or damaged skin
  • Ischemia (cutaneous)
  • Allergy against nickel
  • Allergy against silicone
  • Any Medication (except birth control pill)
  • Known infection with multiresistant bacteria
  • Implanted devices (e.g. pacemaker, pumps)
  • Rhythmogenic heart disease (e.g. resting heart rate > 120/min)
  • Severe or untreated arterial hypertension (blood pressure > 140mmHg systolic, >90mmHg diastolic)
  • Hypotension (blood pressure < 90mmHg systolic, < 60 mmHg diastolic)
  • Current alcohol or drug abuse, alcohol consumption the same day as the study
  • Consumption of coffee 7h before
  • Implanted devices (e.g. pacemaker, pumps)
  • Known sleep-wake disorders
  • Dark skin pigmentation
  • Severe metabolic disease (e.g. diabetes)
  • Pregnancy or lactation
  • Physical handicap effecting the two arms
  • Wound in the wrist region
  • Too large or too small wrist
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sebastian R. Ott, MD +41316323490 sebastian.ott@extern.insel.ch
Contact: Kurt De Jaegere +41316323490 kurt.dejaegere@extern.insel.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03823105
Other Study ID Numbers  ICMJE 2018-00917
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University Hospital Inselspital, Berne
Study Sponsor  ICMJE University Hospital Inselspital, Berne
Collaborators  ICMJE
  • University of Bern
  • CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
Investigators  ICMJE
Principal Investigator: Sebastian R. Ott, MD University Hospital Berne, Department of Pulmonary Medicine
PRS Account University Hospital Inselspital, Berne
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP