Sleep-Wake DisordersNCT03823105
Validation of Non-invasive Miniature Optical Sensors for Scoring Sleep Stages
A study testing OHR Tracker and PulseWatch in people with Sleep-Wake Disorders and Healthy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Validation of two devices with optical sensor in healthy participants and patients with sleep wake disorders. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep-Wake Disorders, Healthy
- What is being tested?
- OHR Tracker and PulseWatch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Dec 2018to 10 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 ≤ Age ≤ 80 years
- Suspected sleep wake disorder (sleep apnea, sleep movement disorders, hypersomnia, parasomnia)
- Written informed consent
- 18 ≤ Age ≤ 80 years
- Written informed consent
Who cannot join
- 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
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- 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
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Bern (Inselspital), Department of Pulmonary Medicine
Bern, 3010
About this study
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
Validation of two devices with optical sensor in healthy participants and patients with sleep wake disorders.
Read the 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.
- Conditions
- Sleep-Wake Disorders, Healthy
- Being tested
- OHR Tracker and PulseWatch
- Keywords
- Sleep apnea, Hypersomnia, Parasomnia
- Medical subject headings
- Sleep Wake Disorders, Sleep Apnea Syndromes, Disorders of Excessive Somnolence, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OHR Tracker and PulseWatchDevice
Category A (ClinO). Medical study with CE-marked medical devices to photoplethysmographic measure heart rate, heart rate variability, and pulse wave and accelerometric data
| Study group | Role | What they receive |
|---|---|---|
| Nocturnal Recording | Experimental | Recording of photoplethysmographic pulse wave and accelerometry with two devices (OHR Tracker, PulseWatch) in parallel to the standard polysomnography Receives: Device: OHR Tracker and PulseWatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time (TST) and sleep architecture (distribution of sleep stages)
Diagnostic accuracy of the new algorithm compared to the Gold Standard full polysomnography
Measured: 1 night
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
Measured: 1 night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start6 Dec 2018
- Primary completion1 Apr 2020
- Study completion10 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep-Wake DisordersStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern, CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
- Responsible party
- Sponsor
- Investigators
- Sebastian R. Ott, MD, Principal investigator, University Hospital Berne, Department of Pulmonary Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823105
- Sponsor's protocol ID
- 2018-00917
- Other IDs
- 2018
- Status last verified
- Jun 2020
- First submitted
- 29 Jan 2019
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03823105
- Acronym / sponsor ID
- 2018-00917
- Conditions
- Sleep-Wake Disorders, Healthy
- Keywords
- Sleep apnea, Hypersomnia, Parasomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern, CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nocturnal Recording | Experimental | Device: OHR Tracker and PulseWatchRecording of photoplethysmographic pulse wave and accelerometry with two devices (OHR Tracker, PulseWatch) in parallel to the standard polysomnography |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 ≤ Age ≤ 80 years
- Suspected sleep wake disorder (sleep apnea, sleep movement disorders, hypersomnia, parasomnia)
- Written informed consent
- 18 ≤ Age ≤ 80 years
- Written informed consent
Key exclusion criteria (39 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OHR Tracker and PulseWatchCategory A (ClinO). Medical study with CE-marked medical devices to photoplethysmographic measure heart rate, heart rate variability, and pulse wave and accelerometric data | Device | Nocturnal Recording |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian R. Ott, MD principal investigator
University Hospital Berne, Department of Pulmonary Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OHR Tracker and PulseWatch in people with Sleep-Wake Disorders and Healthy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Sleep Time (TST) and sleep architecture (distribution of sleep stages) (time frame: 1 night). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.