Breathing rate monitoring with a wearable device in patients with obstructive sleep apnea
| ISRCTN | ISRCTN13965929 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13965929 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | W20_453 # 20.501 |
| Sponsor | Stichting Haaglanden Clinics |
| Funder | Corsano Health B.V. |
- Submission date
- 28/08/2021
- Registration date
- 06/09/2021
- Last edited
- 06/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Sleep apnea is when your breathing stops and starts while you sleep. The most common type is called obstructive sleep apnea (OSA).
This study is aimed at assessing the accuracy of a new non-invasive, continuous, wrist-worn and wireless monitoring PPG device (Corsano CardioWatch 287) in measuring respiration rate and pulse rate at rest.
Who can participate?
Adults suspected for obstructive sleep apnea and healthy volunteers.
What does the study involve?
All participants receive respiration rate and heart rate monitoring simultaneously by a wrist-worn wearable and by respiratory polygraphy, which includes wearing bands around the chest and abdomen, and a pulse-oximeter. The measurements last one full night.
What are the possible benefits and risks of participating?
There are no direct benefits for the participants involved, since the measurements by the investigational device will not be consulted for diagnosis. There are no direct risks for the participants involved.
Where is the study run from?
Department of Sleep Medicine, Haaglanden Clinics, Nieuwe Parklaan 11, The Hague, The Netherlands
When is the study starting and how long is it expected to run for?
September 2020 to March 2021
Who is funding the study?
Corsano Health B.V. (unrestricted grant)
Who is the main contact?
Jacky Gehring, j.gehring@haaglandenclinics.nl
Contact information
Scientific
Nieuwe Parklaan 11
Den Haag
2597 LA
Netherlands
 ORCID ID |
0000-0001-9595-447X |
|---|---|
| Phone | +31 649933066 |
| j.gehring@haaglandenclinics.nl |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre observational study |
| Secondary study design | Cross sectional study |
| Participant information sheet | 40338_PIS.pdf |
| Scientific title | Continuous respiration rate monitoring using photoplethysmography technology in patients with obstructive sleep apnea |
| Study objectives | The mean absolute error and root mean square deviation of respiration rate measured by the Corsano CardioWatch 287 compared to respiratory polygraphy are hypothesized to be less than 1 breath per minute. |
| Ethics approval(s) | Approved 22/10/2020, Medisch Ethische Toetsingscommissie AMC (Meibergdreef 9 1105 AZ Amsterdam, The Netherlands; +31 (0) 20-5667389; no email provided), ref: W20_453 # 20.501 |
| Health condition(s) or problem(s) studied | Obstructive sleep apnea |
| Intervention | Subjects with and without diagnosed Obstructive Sleep Apnea (OSA) will undergo simultaneous, continuous overnight PPG and respiratory polygraphy (RP), which includes respiratory inductance plethysmography and pulse-oximetry, for one night. The PPG sensor’s respiration rate and pulse rate measurement accuracy will be assessed through Bland Altman and correlation analysis. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Corsano CardioWatch 287-1 |
| Primary outcome measure(s) | Respiration rate and heart rate as measured by the Corsano CardioWatch 287 and respiratory polygraphy, continuously for one night |
| Key secondary outcome measure(s) | There are no secondary outcome measures |
| Completion date | 11/03/2021 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 26 |
| Total final enrolment | 26 |
| Key inclusion criteria | 1. Patients suspected of Obstructive Sleep Apnea scheduled for overnight respiratory polygraphy, and healthy volunteers 2. Aged 18 years or above |
| Key exclusion criteria | 1. Wearer of cardiac implanted electronic device (Pacemaker, ICD) 2. CardioWatch 287 cannot be worn due to comprehensible reasons (allergic reactions, wounds, amputations, other) 3. Unable or not willing to sign informed consent 4. Significant mental or cognitive impairment 5. Currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject's participation in this study |
| Date of first enrolment | 15/12/2020 |
| Date of final enrolment | 11/03/2021 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Den Haag
2597 LA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Jacky Gehring, srs@jackygehring.nl. The anonymized raw data will be provided for reproduction purposes only, until 10 years after publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 06/09/2021 | No | Yes | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 06/09/2021 | No | No |
Additional files
Editorial Notes
06/09/2021: Trial's existence confirmed by Amsterdam UMC.
