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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

Brief Summary:
Validation of two devices with optical sensor in healthy participants and patients with sleep wake disorders.

Condition or disease Intervention/treatment Phase
Sleep-Wake Disorders Healthy Device: OHR Tracker and PulseWatch Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of Non-invasive Miniature Optical Sensors for Scoring Sleep Stages: a Prospective, Method-comparison, Proof of Concept, Single-centre Phase IV Study
Actual Study Start Date : December 6, 2018
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders

Arm Intervention/treatment
Experimental: Nocturnal Recording
Recording of photoplethysmographic pulse wave and accelometry with two devices (OHR Tracker, PulseWatch) in parallel to the standard polysomnography
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




Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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): NCT03823105


Contacts
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Contact: Sebastian R. Ott, MD +41316323490 sebastian.ott@extern.insel.ch
Contact: Kurt De Jaegere +41316323490 kurt.dejaegere@extern.insel.ch

Locations
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Switzerland
University Hospital Bern (Inselspital), Department of Pulmonary Medicine Recruiting
Bern, Switzerland, 3010
Contact: Sebastian R. Ott, MD    +41316323490    sebastian.ott@extern.insel.ch   
Contact: Kurt De Jaegere    +41316323490    kurt.dejaegere@extern.insel.ch   
Principal Investigator: Sebastian R. Ott, MD         
Sub-Investigator: Thomas K. Geiser, MD         
Sub-Investigator: Anne-Kathrin Brill, MD         
Sub-Investigator: Christian Horvath, MD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Bern
CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
Investigators
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Principal Investigator: Sebastian R. Ott, MD University Hospital Berne, Department of Pulmonary Medicine

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03823105     History of Changes
Other Study ID Numbers: 2018-00917
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Inselspital, Berne:
Sleep apnea
Hypersomnia
Parasomnia
Additional relevant MeSH terms:
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Sleep Wake Disorders
Parasomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders