Obstructive Sleep ApneaNCT05049135
Feasibility of a Sensor-less Sleep Monitor (Somnofy®) in Diagnosis and Follow-up in Obstructive Sleep Apnea.
An observational study of Obstructive Sleep Apnea, run by Helse Nord-Trøndelag HF at 1 site in Norway.
Trial summary
To evaluate the feasibility of a sensor-less sleep monitor (Somnofy®) in diagnosis and follow-up in obstructive sleep apnea. The study will explore the monitor's usefulness in detection of apnea during sleep, and compare the data to standard diagnostic registrations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Somnofy® sleep monitor
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2021to 7 Mar 2023
- Phase
- Observational
- 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
Study population: Patents with undiagnosed suspected sleep apnea who are referred to Levanger Hospital for respiratory polygraphy, and their partners
Who may be able to join
- referred to the pulmonology department in the participating hospital (Sykehuset Levanger) with suspected sleep apnea
- able to sign an informed consent
Who cannot join
- Pregnancy
- Serious disease which could affect ability to complete the study
- Complicated sleep disorders
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Pulmonology, Levanger Hospital, North Trøndelag Hospital Trust
Levanger
About this study
Official title: Long Distance Diagnostics of Sleep Apnea With Objective Sleep Data From a Sensor-less Monitor - a Feasibility Study
To evaluate the feasibility of a sensor-less sleep monitor (Somnofy®) in diagnosis and follow-up in obstructive sleep apnea. The study will explore the monitor's usefulness in detection of apnea during sleep, and compare the data to standard diagnostic registrations.
Read the detailed description
A single-center prospective feasibility study. The study device is Somnofy®, a sensor-less commercially available sleep monitor. The ability of the monitor to detect apneas or hypopneas based on ultra wideband radar technology will be evaluated. The Somnofy® radar data will be compared with the diagnostic data from the predicate polygraph device NOX-T3 and the OSAS event data from the Metronics AirView software from CPAP. Thus, it will be possible to assess if Somnofy® is able to detect the events registered from the diagnostic equipment. For patients started on Continous Positive Airway Pressure (CPAP) treatment, a new registration with Somnofy® will be performed 12 weeks after treatment initiation. The effect of obstructive sleep apnea on patient and partner reported outcomes before and after CPAP initiation will also be assessed through questionnaires and journals.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Somnofy® sleep monitor
- Keywords
- sleep monitor
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somnofy® sleep monitorDevice
Also called Respiratory polygraphy (NOXT3, ResMed AS)
Registration of sleep score and apneas with radar sensor technology at time of primary investigation and 12 weeks after treatment initiation with continuous positive airway pressure (CPAP)
| Study group | Role | What they receive |
|---|---|---|
| Sleep apnea group | Patients with undiagnosed suspected sleep apnea who are referred to Levanger Hospital for respiratory polygraphy Receives: Device: Somnofy® sleep monitor | |
| Control group | partners of patients with undiagnosed suspected sleep apnea who are referred to Levanger Hospital for respiratory polygraphy Receives: Device: Somnofy® sleep monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea/hypopnea index
Apnea/hypopnea index defined as the number of apneas or hypopneas per hours of sleep
Measured: 72 hours
Secondary outcomes (1)
Sleep score
Objective (AI-based) score of sleep quality from raw data from sleep monitor
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start1 Sep 2021
- Primary completion31 Dec 2022
- Study completion7 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Nord-Trøndelag HF
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, VitalThings
- Responsible party
- Sponsor
- Investigators
- Øystein Risa, PhD, Study director, NTNU, Fac of Med and Health Sci, Dept of Circulation and Medical ImagingCarl Platou, MD, Study director, North Trøndelag Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049135
- Sponsor's protocol ID
- 200405
- Other IDs
- CIV-NO-21-08-037486
- Status last verified
- Mar 2023
- First submitted
- 9 Sep 2021
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Distance Diagnostics of Sleep Apnea With Objective Sleep Data From a Sensor-less Monitor - a Feasibility Study
- ClinicalTrials.gov ID
- NCT05049135
- Acronym / sponsor ID
- 200405
- Conditions
- Obstructive Sleep Apnea
- Keywords
- sleep monitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Helse Nord-Trøndelag HFUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, VitalThings
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 17 Sep 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 evaluate the feasibility of a sensor-less sleep monitor (Somnofy®) in diagnosis and follow-up in obstructive sleep apnea. The study will explore the monitor's usefulness in detection of apnea during sleep, and compare the data to standard diagnostic registrations.
Detailed description
A single-center prospective feasibility study. The study device is Somnofy®, a sensor-less commercially available sleep monitor. The ability of the monitor to detect apneas or hypopneas based on ultra wideband radar technology will be evaluated. The Somnofy® radar data will be compared with the diagnostic data from the predicate polygraph device NOX-T3 and the OSAS event data from the Metronics AirView software from CPAP. Thus, it will be possible to assess if Somnofy® is able to detect the events registered from the diagnostic equipment. For patients started on Continous Positive Airway Pressure (CPAP) treatment, a new registration with Somnofy® will be performed 12 weeks after treatment initiation. The effect of obstructive sleep apnea on patient and partner reported outcomes before and after CPAP initiation will also be assessed through questionnaires and journals.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep apnea group | – | Device: Somnofy® sleep monitorPatients with undiagnosed suspected sleep apnea who are referred to Levanger Hospital for respiratory polygraphy |
| Control group | – | Device: Somnofy® sleep monitorpartners of patients with undiagnosed suspected sleep apnea who are referred to Levanger Hospital for respiratory polygraphy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patents with undiagnosed suspected sleep apnea who are referred to Levanger Hospital for respiratory polygraphy, and their partners
Key inclusion criteria (2 listed)
- referred to the pulmonology department in the participating hospital (Sykehuset Levanger) with suspected sleep apnea
- able to sign an informed consent
Key exclusion criteria (3 listed)
- Pregnancy
- Serious disease which could affect ability to complete the study
- Complicated sleep disorders
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 |
|---|---|---|
| Somnofy® sleep monitorAlso: Respiratory polygraphy (NOXT3, ResMed AS)Registration of sleep score and apneas with radar sensor technology at time of primary investigation and 12 weeks after treatment initiation with continuous positive airway pressure (CPAP) | Device | Control group, Sleep apnea group |
Primary outcome
Apnea/hypopnea index
Time frame: 72 hours
Apnea/hypopnea index defined as the number of apneas or hypopneas per hours of sleep
1 secondary outcome
Sleep score
Time frame: 12 weeks
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 20 Mar 2023.
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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.
Øystein Risa, PhD study director
NTNU, Fac of Med and Health Sci, Dept of Circulation and Medical Imaging
Carl Platou, MD study director
North Trøndelag Hospital Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Helse Nord-Trøndelag HF at 1 site in Norway.
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 3 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 20 Mar 2023. 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 Norway. 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?
Apnea/hypopnea index (time frame: 72 hours). 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 20 Mar 2023.