Sleep ApneaNCT04803552
Non-contact Sleep Apnea Identification in Neurological Rehabilitation
A study testing Overnight sleep study with Sleepiz One and a respiratory polygraphy in people with Sleep Apnea and Stroke, run by Sleepiz AG at 1 site in Switzerland.
Trial summary
To improve the quality of medical care in the group of poststroke patients, we are planning to examine neurological patients in a rehabilitation clinic simultaneously with a non-contact method (Sleepiz One) and a standard diagnostic polygraphy measurement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Stroke
- What is being tested?
- Overnight sleep study with Sleepiz One and a respiratory polygraphy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Apr 2021to 31 Aug 2022
- 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
- Age >18years
- Ability and consent to undergo electrophysiological routine assessment
- Informed Consent as documented by signature
- In-patients of RehaClinic Bad Zurzach
Who cannot join
- Previous enrolment into the current study,
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- Cardiac pacemaker or another implanted electrical device
- Women who are pregnant or breastfeeding
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, delirium etc. of the participant
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
KSM Bad Zurzach
Bad Zurzach, Canton of Aargau, 5330
Jens Acker, jens.acker@zurzachcare.ch
About this study
Official title: Identification of Patients With Clinically Relevant Sleep Apnea With a Contactless Device in Rehabilitation Clinic
To improve the quality of medical care in the group of poststroke patients, we are planning to examine neurological patients in a rehabilitation clinic simultaneously with a non-contact method (Sleepiz One) and a standard diagnostic polygraphy measurement. This easy and comfortable pre-screening (Sleepiz One) should reduce the barrier for ward physicians to request a sleep study. The method could help to overcome the bottleneck of resource-intense procedures. It is simple to carry out and does not disturb the sleep of the patients.
The scoring is done according to the AASM Manual Version 2.6. Patients with a confirmed diagnosis will be informed about therapy options by a sleep physician and receive a recommendation for further therapy in the discharge letter from the rehabilitation clinic.
The goal of the study is then to evaluate if a non-contact method, the Sleepiz One, presents an opportunity for a fast and easy pre-screening during rehabilitation. Therefore, the precision of binary classification of subjects based on their sleep apnea severity (AHI >= 15) made by Sleepiz One will be compared to PG data manually scored by expert sleep scorers.
- Conditions
- Sleep Apnea, Stroke
- Being tested
- Overnight sleep study with Sleepiz One and a respiratory polygraphy
- Keywords
- stroke, sleep apnea, contactless, screening
- Medical subject headings
- Sleep Apnea Syndromes, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overnight sleep study with Sleepiz One and a respiratory polygraphyDevice
Participants will undergo a screening night with Sleepiz One. and with a cardiorespiratory polygraphy device (Miniscreen, Heinen-Löwenstein).
Measurements (Miniscreen, Heinen-Löwenstein)
- Thoracic respiratory effort: respiration frequency (BR), respiration curve
- Airflow: respiration frequency (BR), respiration curve
- Body movement: body position
- Blood oxygen saturation (SpO2)
- Pulse
Measurements (Sleepiz One):
- Movement originating from breathing and heart contractions
| Study group | Role | What they receive |
|---|---|---|
| Contactless sleep apnea screening vs respiratory polygraphy | Experimental | Not described Receives: Device: Overnight sleep study with Sleepiz One and a respiratory polygraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binary classification of the apnea severity
Precision of binary classification of subjects based on their sleep apnea severity (apnea-hypopnea index (AHI) >= 15) made by Sleepiz One, compared to PG data manually scored by expert sleep scorers
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 posted17 Mar 2021
- Study start15 Apr 2021
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sleepiz AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jens Acker, Dr., Principal investigator, KSM Bad Zurzach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803552
- Sponsor's protocol ID
- 20-025-EX-KSM Bad Zurzach
- Status last verified
- Jan 2022
- First submitted
- 16 Mar 2021
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Patients With Clinically Relevant Sleep Apnea With a Contactless Device in Rehabilitation Clinic
- ClinicalTrials.gov ID
- NCT04803552
- Acronym / sponsor ID
- 20-025-EX-KSM Bad Zurzach
- Conditions
- Sleep Apnea, Stroke
- Keywords
- stroke, sleep apnea, contactless, screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Sleepiz AGIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 17 Mar 2021 (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.
To improve the quality of medical care in the group of poststroke patients, we are planning to examine neurological patients in a rehabilitation clinic simultaneously with a non-contact method (Sleepiz One) and a standard diagnostic polygraphy measurement. This easy and comfortable pre-screening (Sleepiz One) should reduce the barrier for ward physicians to request a sleep study. The method could help to overcome the bottleneck of resource-intense procedures. It is simple to carry out and does not disturb the sleep of the patients.
The scoring is done according to the AASM Manual Version 2.6. Patients with a confirmed diagnosis will be informed about therapy options by a sleep physician and receive a recommendation for further therapy in the discharge letter from the rehabilitation clinic.
The goal of the study is then to evaluate if a non-contact method, the Sleepiz One, presents an opportunity for a fast and easy pre-screening during rehabilitation. Therefore, the precision of binary classification of subjects based on their sleep apnea severity (AHI >= 15) made by Sleepiz One will be compared to PG data manually scored by expert sleep scorers.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contactless sleep apnea screening vs respiratory polygraphy | Experimental | Device: Overnight sleep study with Sleepiz One and a respiratory polygraphy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18years
- Ability and consent to undergo electrophysiological routine assessment
- Informed Consent as documented by signature
- In-patients of RehaClinic Bad Zurzach
Key exclusion criteria (5 listed)
- Previous enrolment into the current study,
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- Cardiac pacemaker or another implanted electrical device
- Women who are pregnant or breastfeeding
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, delirium etc. of the participant
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 |
|---|---|---|
| Overnight sleep study with Sleepiz One and a respiratory polygraphyParticipants will undergo a screening night with Sleepiz One. and with a cardiorespiratory polygraphy device (Miniscreen, Heinen-Löwenstein). Measurements (Miniscreen, Heinen-Löwenstein) * Thoracic respiratory effort: respiration frequency (BR), respiration curve * Airflow: respiration frequency (BR), respiration curve * Body movement: body position * Blood oxygen saturation (SpO2) * Pulse Measurements (Sleepiz One): • Movement originating from breathing and heart contractions | Device | Contactless sleep apnea screening vs respiratory polygraphy |
Primary outcome
Binary classification of the apnea severity
Time frame: 1 night
Precision of binary classification of subjects based on their sleep apnea severity (apnea-hypopnea index (AHI) >= 15) made by Sleepiz One, compared to PG data manually scored by expert sleep scorers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- 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.
Jens Acker, Dr. principal investigator
KSM Bad Zurzach
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overnight sleep study with Sleepiz One and a respiratory polygraphy in people with Sleep Apnea and Stroke, run by Sleepiz AG 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jens Acker, Dr. (+41 56 269 60 20, j.acker@ksm.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binary classification of the apnea severity (time frame: 1 night). 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 8 Feb 2022.