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

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Completed
CT.gov ID
NCT03823105
Collaborator
University of Bern (Other), CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement (Industry)
69
Enrollment
1
Location
1
Arm
18.1
Actual Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: OHR Tracker and PulseWatch
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
69 participants
Allocation:
N/A
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 :
Dec 6, 2018
Actual Primary Completion Date :
Apr 1, 2020
Actual Study Completion Date :
Jun 10, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Nocturnal Recording

Recording of photoplethysmographic pulse wave and accelerometry 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 accelerometric data

Outcome Measures

Primary Outcome Measures

  1. Total Sleep Time (TST) and sleep architecture (distribution of sleep stages) [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 [1 night]

    Diagnostic accuracy of the new algorithm compared to the Gold Standard full polysomnography

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Bern (Inselspital), Department of Pulmonary Medicine Bern Switzerland 3010

Sponsors and Collaborators

  • University Hospital Inselspital, Berne
  • University of Bern
  • CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement

Investigators

  • Principal Investigator: Sebastian R. Ott, MD, University Hospital Berne, Department of Pulmonary Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT03823105
Other Study ID Numbers:
  • 2018-00917
First Posted:
Jan 30, 2019
Last Update Posted:
Jun 11, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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:
Sleep Wake Disorders

Study Results

No Results Posted as of Jun 11, 2020