Sleep-Disordered BreathingNCT02760680
Validation of the Peripheral Arterial Tone to Detect Sleep-disordered Breathing in Patients With Chronic Heart Failure
A study testing WatchPAT 200 (TM) and Polysomnography in people with Sleep-Disordered Breathing, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
Trial summary
A prospective validation study: Level I-full night-polysomnography (PSG) versus a diagnostic device with measurement of the peripheral arterial tone (PAT) of patients with chronic heart failure (CHF) and sleep-disordered breathing (SDB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep-Disordered Breathing
- What is being tested?
- WatchPAT 200 (TM) and Polysomnography
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2015to Jul 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- reduced left ventricular ejection fraction (LVEF) < 45 %
- indication for a polysomnography
Who cannot join
- allergies against the device or parts of the device
- psychogenic or neurological disorders which do not allow a sufficient patient compliance
- osteogenetic disorders which do not allow a painless investigation
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen
Bad Oeynhausen, North Rhine-Westphalia, 32545
About this study
Official title: Validierung Der Peripher Arteriellen Tonometrie Zur Diagnostik Schlafbezogener Atmungsstörungen Bei Patienten Mit Systolischer Herzinsuffizienz
A prospective validation study: Level I-full night-polysomnography (PSG) versus a diagnostic device with measurement of the peripheral arterial tone (PAT) of patients with chronic heart failure (CHF) and sleep-disordered breathing (SDB).
Read the detailed description
Patients with chronic heart failure (CHF), reduced left ventricular ejection fraction (LVEF<45%) and predicted sleep-disordered breathing (SDB) receive a diagnostic device (WatchPAT 200 (TM)) and polysomnography (PSG) simultaneously during on night in a hospital sleep lab.
The WatchPAT 200 (TM) is a wrist worn diagnostic device for detecting SDB. Its main part is the measurement of the peripheral arterial tone (PAT) via a plethysmographic based finger-mounted probe. It can measure the level of sympathetic activation of the autonomic nervous system. Pulse rate, oxygen saturation and snoring/body position levels are calculated, too. A software program (zzzPAT (TM)) with a special algorithm analyzes the raw data and creates a sleep report. Therefore the property of the WatchPAT 200 (TM) proclaims that the WatchPAT 200 (TM) can detect sleep events and SDB.
The PSG is scored by sleep lab physicians/technicians blinded to the zzzPAT (TM)-software results using current American Academy of Sleep Medicine (AASM) guidelines.
Both results will be compared and the results of the device will be validated and evaluated against the results of the "Gold Standard" polysomnography.
- Conditions
- Sleep-Disordered Breathing
- Being tested
- WatchPAT 200 (TM), Polysomnography
- Keywords
- Chronic Heart Failure, Sleep-Disordered Breathing, Peripheral Arterial Tone
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WatchPAT 200 (TM)Device
Also called PAT (TM) - Watch-PAT 200, Itamar-Medical Ltd., Israel
The WatchPAT 200 (TM) is a wrist worn diagnostic device for detecting SDB. Its main part is the measurement of the peripheral arterial tone (PAT) via a plethysmographic based finger-mounted probe. It can measure the level of sympathetic activation of the autonomic nervous system. Pulse rate, oxygen saturation and snoring/body position levels are calculated, too. A software program (zzzPAT (TM)) with a special algorithm analyzes the raw data and creates a sleep report. Therefore the property of the WatchPAT 200 (TM) proclaims that the WatchPAT 200 (TM) can detect sleep events and SDB.
PolysomnographyOther
The PSG is known as the "Gold Standard" for detecting SDB: experienced sleep physicians and technicians score events (apnea/hypopnea) using current AASM Guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Polysomnography | Placebo comparator | The PSG is known as the "Gold Standard" for detecting SDB: experienced sleep physicians and technicians score events (apnea/hypopnea) using current AASM Guidelines. Receives: Device: WatchPAT 200 (TM); Other: Polysomnography |
| Diagnostic Device (WatchPAT 200 (TM)) | Active comparator | The WatchPAT 200 (TM) is a wrist worn diagnostic device for detecting SDB. Its main part is the measurement of the peripheral arterial tone (PAT) via a plethysmographic based finger-mounted probe. It can measure the level of sympathetic activation of the autonomic nervous system. Pulse rate, oxygen saturation and snoring/body position levels are calculated, too. A software program (zzzPAT (TM)) with a special algorithm analyzes the raw data and creates a sleep report. Therefore the property of the WatchPAT 200 (TM) proclaims that the WatchPAT 200 (TM) can detect sleep events and SDB. Receives: Device: WatchPAT 200 (TM); Other: Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea-Index (AHI)
Index is stated per hour (/h)
Measured: one night of sleep
Secondary outcomes (31)
Sleep: Time in bed
stated in minutes (min)
Measured: one night of sleep
Sleep: Total sleep time
stated in minutes (min)
Measured: one night of sleep
Sleep: Sleep latency
stated in minutes (min)
Measured: one night of sleep
Sleep: Rapid-Eye-Movement (REM) sleep latency
stated in minutes (min)
Measured: one night of sleep
Sleep: latency to S3
stated in minutes (min)
Measured: one night of sleep
Sleep: Wake
stated in percent (%)
Measured: one night of sleep
Sleep: S1 stadium/total sleep time
stated in percent (%)
Measured: one night of sleep
Sleep: S2 stadium/total sleep time
stated in percent (%)
Measured: one night of sleep
Sleep: S3 stadium/total sleep time
stated in percent (%)
Measured: one night of sleep
Sleep: REM sleep/total sleep time
stated in percent (%)
Measured: one night of sleep
Sleep: Sleep Efficiency
amount of sleep, stated in percent (%)
Measured: one night of sleep
Sleep: Number of Wakes
stated as number
Measured: one night of sleep
Respiratory Parameters: Oxygen-Desaturation-Index (ODI)
Index is stated per hour (/h)
Measured: one night of sleep
Respiratory Parameters: longest Apnea
stated in seconds (s)
Measured: one night of sleep
Respiratory Parameters: longest Hypopnea
stated in seconds (s)
Measured: one night of sleep
Respiratory Parameters: Obstructive Apnea
Index is stated per hour (/h), stated as number
Measured: one night of sleep
Respiratory Parameters: Central Apnea
Index is stated per hour (/h), stated as number
Measured: one night of sleep
Respiratory Parameters: Mixed Apnea
Index is stated per hour (/h), stated as number
Measured: one night of sleep
Respiratory Parameters: Obstructive Hypopnea
Index is stated per hour (/h), stated as number
Measured: one night of sleep
Respiratory Parameters: Central Hypopnea
Index is stated per hour (/h), stated as number
Measured: one night of sleep
Respiratory Parameters: Hypopnea total
Index is stated per hour (/h), stated as number
Measured: one night of sleep
Respiratory Parameters: Apnea + Hypopnea total
Index is stated per hour (/h), stated as number
Measured: one night of sleep
Respiratory Parameters: Desaturations
Index is stated per hour (/h), stated as number
Measured: one night of sleep
Respiratory Parameters: Mean Oxygen Saturation (sO2)
stated in percent (%)
Measured: one night of sleep
Respiratory Parameters: Minimum Oxygen Saturation (sO2)
stated in percent (%)
Measured: one night of sleep
Respiratory Parameters: Maximum Oxygen Saturation (sO2)
stated in percent (%)
Measured: one night of sleep
Respiratory Parameters: Mean of Desaturations Nadirs
stated in percent (%)
Measured: one night of sleep
Respiratory Parameters: Mean of Desaturations
stated in percent (%)
Measured: one night of sleep
Respiratory Parameters: Time Oxygen Saturation (TsO2) < 90%
stated in percent (%), stated in minutes (min)
Measured: one night of sleep
Respiratory Parameters: Respiratory-Disturbance-Index (RDI)
Index is stated per hour (/h)
Measured: one night of sleep
Differences of results of patients with central sleep apnea (CSA) or obstructive sleep apnea (OSA)
Comparison of all Parameters added above
Measured: one night of sleep
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startMar 2015
- Primary completionJun 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep-Disordered BreathingStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Sponsor type
- University, hospital or other
- Collaborators
- Itamar-Medical, Israel
- Responsible party
- Principal investigator, Thomas Bitter, Heart and Diabetes Center North-Rhine Westfalia
- Investigators
- Thomas Bitter, MD, Study director, Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, GermanyFlorian Schindhelm, Principal investigator, Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760680
- Sponsor's protocol ID
- HDZNRW-KA_005_TB
- Status last verified
- Mar 2017
- First submitted
- 20 Apr 2016
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bar A, Pillar G, Dvir I, Sheffy J, Schnall RP, Lavie P. Evaluation of a portable device based on peripheral arterial tone for unattended home sleep studies. Chest. 2003 Mar;123(3):695-703. doi: 10.1378/chest.123.3.695.
PubMed 12628865
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validierung Der Peripher Arteriellen Tonometrie Zur Diagnostik Schlafbezogener Atmungsstörungen Bei Patienten Mit Systolischer Herzinsuffizienz
- ClinicalTrials.gov ID
- NCT02760680
- Acronym / sponsor ID
- HDZNRW-KA_005_TB
- Conditions
- Sleep-Disordered Breathing
- Keywords
- Chronic Heart Failure, Sleep-Disordered Breathing, Peripheral Arterial Tone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Heart and Diabetes Center North-Rhine WestfaliaUniversity, hospital or other
- Collaborators
- Itamar-Medical, Israel
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 4 May 2016 (estimated)
- 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.
A prospective validation study: Level I-full night-polysomnography (PSG) versus a diagnostic device with measurement of the peripheral arterial tone (PAT) of patients with chronic heart failure (CHF) and sleep-disordered breathing (SDB).
Detailed description
Patients with chronic heart failure (CHF), reduced left ventricular ejection fraction (LVEF<45%) and predicted sleep-disordered breathing (SDB) receive a diagnostic device (WatchPAT 200 (TM)) and polysomnography (PSG) simultaneously during on night in a hospital sleep lab.
The WatchPAT 200 (TM) is a wrist worn diagnostic device for detecting SDB. Its main part is the measurement of the peripheral arterial tone (PAT) via a plethysmographic based finger-mounted probe. It can measure the level of sympathetic activation of the autonomic nervous system. Pulse rate, oxygen saturation and snoring/body position levels are calculated, too. A software program (zzzPAT (TM)) with a special algorithm analyzes the raw data and creates a sleep report. Therefore the property of the WatchPAT 200 (TM) proclaims that the WatchPAT 200 (TM) can detect sleep events and SDB.
The PSG is scored by sleep lab physicians/technicians blinded to the zzzPAT (TM)-software results using current American Academy of Sleep Medicine (AASM) guidelines.
Both results will be compared and the results of the device will be validated and evaluated against the results of the "Gold Standard" polysomnography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polysomnography | Placebo comparator | Device: WatchPAT 200 (TM), Other: PolysomnographyThe PSG is known as the "Gold Standard" for detecting SDB: experienced sleep physicians and technicians score events (apnea/hypopnea) using current AASM Guidelines. |
| Diagnostic Device (WatchPAT 200 (TM)) | Active comparator | Device: WatchPAT 200 (TM), Other: PolysomnographyThe WatchPAT 200 (TM) is a wrist worn diagnostic device for detecting SDB. Its main part is the measurement of the peripheral arterial tone (PAT) via a plethysmographic based finger-mounted probe. It can measure the level of sympathetic activation of the autonomic nervous system. Pulse rate, oxygen saturation and snoring/body position levels are calculated, too. A software program (zzzPAT (TM)) with a special algorithm analyzes the raw data and creates a sleep report. Therefore the property of the WatchPAT 200 (TM) proclaims that the WatchPAT 200 (TM) can detect sleep events and SDB. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- reduced left ventricular ejection fraction (LVEF) < 45 %
- indication for a polysomnography
Key exclusion criteria (4 listed)
- allergies against the device or parts of the device
- psychogenic or neurological disorders which do not allow a sufficient patient compliance
- osteogenetic disorders which do not allow a painless investigation
- pregnancy
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 |
|---|---|---|
| WatchPAT 200 (TM)Also: PAT (TM) - Watch-PAT 200, Itamar-Medical Ltd., IsraelThe WatchPAT 200 (TM) is a wrist worn diagnostic device for detecting SDB. Its main part is the measurement of the peripheral arterial tone (PAT) via a plethysmographic based finger-mounted probe. It can measure the level of sympathetic activation of the autonomic nervous system. Pulse rate, oxygen saturation and snoring/body position levels are calculated, too. A software program (zzzPAT (TM)) with a special algorithm analyzes the raw data and creates a sleep report. Therefore the property of the WatchPAT 200 (TM) proclaims that the WatchPAT 200 (TM) can detect sleep events and SDB. | Device | Diagnostic Device (WatchPAT 200 (TM)), Polysomnography |
| PolysomnographyThe PSG is known as the "Gold Standard" for detecting SDB: experienced sleep physicians and technicians score events (apnea/hypopnea) using current AASM Guidelines. | Other | Diagnostic Device (WatchPAT 200 (TM)), Polysomnography |
Primary outcome
Apnea-Hypopnea-Index (AHI)
Time frame: one night of sleep
Index is stated per hour (/h)
31 secondary outcomes
Sleep: Time in bed
Time frame: one night of sleep
Sleep: Total sleep time
Time frame: one night of sleep
Sleep: Sleep latency
Time frame: one night of sleep
Sleep: Rapid-Eye-Movement (REM) sleep latency
Time frame: one night of sleep
Sleep: latency to S3
Time frame: one night of sleep
Sleep: Wake
Time frame: one night of sleep
Sleep: S1 stadium/total sleep time
Time frame: one night of sleep
Sleep: S2 stadium/total sleep time
Time frame: one night of sleep
Sleep: S3 stadium/total sleep time
Time frame: one night of sleep
Sleep: REM sleep/total sleep time
Time frame: one night of sleep
Sleep: Sleep Efficiency
Time frame: one night of sleep
Sleep: Number of Wakes
Time frame: one night of sleep
Respiratory Parameters: Oxygen-Desaturation-Index (ODI)
Time frame: one night of sleep
Respiratory Parameters: longest Apnea
Time frame: one night of sleep
Respiratory Parameters: longest Hypopnea
Time frame: one night of sleep
Respiratory Parameters: Obstructive Apnea
Time frame: one night of sleep
Respiratory Parameters: Central Apnea
Time frame: one night of sleep
Respiratory Parameters: Mixed Apnea
Time frame: one night of sleep
Respiratory Parameters: Obstructive Hypopnea
Time frame: one night of sleep
Respiratory Parameters: Central Hypopnea
Time frame: one night of sleep
Respiratory Parameters: Hypopnea total
Time frame: one night of sleep
Respiratory Parameters: Apnea + Hypopnea total
Time frame: one night of sleep
Respiratory Parameters: Desaturations
Time frame: one night of sleep
Respiratory Parameters: Mean Oxygen Saturation (sO2)
Time frame: one night of sleep
Respiratory Parameters: Minimum Oxygen Saturation (sO2)
Time frame: one night of sleep
Respiratory Parameters: Maximum Oxygen Saturation (sO2)
Time frame: one night of sleep
Respiratory Parameters: Mean of Desaturations Nadirs
Time frame: one night of sleep
Respiratory Parameters: Mean of Desaturations
Time frame: one night of sleep
Respiratory Parameters: Time Oxygen Saturation (TsO2) < 90%
Time frame: one night of sleep
Respiratory Parameters: Respiratory-Disturbance-Index (RDI)
Time frame: one night of sleep
Differences of results of patients with central sleep apnea (CSA) or obstructive sleep apnea (OSA)
Time frame: one night of sleep
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 16 Mar 2017.
- Background: PubMed 12628865Bar A, Pillar G, Dvir I, Sheffy J, Schnall RP, Lavie P. Evaluation of a portable device based on peripheral arterial tone for unattended home sleep studies. Chest. 2003 Mar;123(3):695-703. doi: 10.1378/chest.123.3.695.
- Official website of Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, GermanyLink provided by the sponsor.
- Official website of Itamar Medical Ltd.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Thomas Bitter, MD study director
Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany
Florian Schindhelm principal investigator
Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WatchPAT 200 (TM) and Polysomnography in people with Sleep-Disordered Breathing, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
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 2 inclusion and 4 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 16 Mar 2017. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
Apnea-Hypopnea-Index (AHI) (time frame: one night of sleep). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02760680, which also lists 1 linked publication.
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 16 Mar 2017.