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

Primary Purpose

Sleep-Wake Disorders, Healthy

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
OHR Tracker and PulseWatch
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep-Wake Disorders focused on measuring Sleep apnea, Hypersomnia, Parasomnia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital Bern (Inselspital), Department of Pulmonary Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nocturnal Recording

Arm Description

Recording of photoplethysmographic pulse wave and accelerometry with two devices (OHR Tracker, PulseWatch) in parallel to the standard polysomnography

Outcomes

Primary Outcome Measures

Total Sleep Time (TST) and sleep architecture (distribution of sleep stages)
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
Diagnostic accuracy of the new algorithm compared to the Gold Standard full polysomnography

Secondary Outcome Measures

Full Information

First Posted
January 29, 2019
Last Updated
June 11, 2020
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
University of Bern, CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
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1. Study Identification

Unique Protocol Identification Number
NCT03823105
Brief Title
Validation of Non-invasive Miniature Optical Sensors for Scoring Sleep Stages
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
December 6, 2018 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
June 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
University of Bern, CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep-Wake Disorders, Healthy
Keywords
Sleep apnea, Hypersomnia, Parasomnia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nocturnal Recording
Arm Type
Experimental
Arm Description
Recording of photoplethysmographic pulse wave and accelerometry with two devices (OHR Tracker, PulseWatch) in parallel to the standard polysomnography
Intervention Type
Device
Intervention Name(s)
OHR Tracker and PulseWatch
Intervention Description
Category A (ClinO). Medical study with CE-marked medical devices to photoplethysmographic measure heart rate, heart rate variability, and pulse wave and accelerometric data
Primary Outcome Measure Information:
Title
Total Sleep Time (TST) and sleep architecture (distribution of sleep stages)
Description
Diagnostic accuracy of the new algorithm compared to the Gold Standard full polysomnography
Time Frame
1 night
Title
The total time in non-REM sleep (stages 1-3), REM sleep, and awake after sleep onset
Description
Diagnostic accuracy of the new algorithm compared to the Gold Standard full polysomnography
Time Frame
1 night

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian R. Ott, MD
Organizational Affiliation
University Hospital Berne, Department of Pulmonary Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Bern (Inselspital), Department of Pulmonary Medicine
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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