Obstructive Sleep Apnea Hypopnea SyndromeSUNPVNCT06460441

Comparison of the SUNRISE© Device With Ventilatory Polygraphy for the Diagnosis of Obstructive Sleep Apnea Hypopnea Syndrome: Collection of Preliminary Data

An observational study of Obstructive Sleep Apnea Hypopnea Syndrome, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Additional data on screening for obstructive sleep apnea/hypopnea syndrome (OSAHS) in patients with co-morbidities, such as diabetics and those with chronic respiratory diseases would enable current recommendations to evolve, with a view to promoting the widespread use of simplified techniques for OSAHS screening… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Obstructive Sleep Apnea Hypopnea Syndrome
What is being tested?: SUNRISE© device
How many people: 37 participants
Where: 1 siteFrance
Study dates: 19 Jun 2024to 28 Feb 2025
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: The study will be proposed to diabetic patients treated in the diabetology department of the Strasbourg University Hospital, as well as to patients referred to the pneumology consultation at the GHRMSA (Mulhouse) who need to have their sleep disorders investigated using ventilatory polygraphy.

Who may be able to join

Patient aged 18 or over;
Patient with a smartphone (Android or iOS) with Bluetooth and Internet connection and able to use the mobile application associated with the Sunrise© medical device;
Patient having a scheduled exploration by ventilatory polygraphy;
Non-opposition to participation in the research.

Who cannot join

Patient suffering from a psychiatric pathology or with a history of behavioral disorders;
Patient already treated for OSAHS;
Patient refusing to cut his beard (if too abundant to wear the Sunrise© device);
Patient suffering from a pathology affecting the rotation of the condyle in the temporomandibular joint;
Patient deprived of liberty by judicial or administrative decision;
Patients under court protection or legal guardianship.

Trial locations and contacts

1 site in 1 country.

France1 site

Hôpitaux Universitaires de Strasbourg
Strasbourg, Bas-Rhin

Other trials in France

About this study

The primary objective of this observational multicentric pilot study is to compare the performance of the Sunrise® medical device with that of ventilatory polygraphy as part of routine screening for OSAHS in diabetic patients followed up in the diabetology department of the Strasbourg University Hospital, and in patients followed up in the pneumology consultation department of Mulhouse Hospital (GHRMSA).

Read the detailed description

Secondary objectives

To assess the correlation of the following parameters:

dorsal Apnea-Hypopnea Index (AHI) measured by ventilatory polygraphy and dorsal Obstructive Respiratory Disturbance Index (ORDI) measured by Sunrise® device
non-dorsal AHI measured by ventilatory polygraphy and non-dorsal ORDI measured by Sunrise® device

To study the correlation between AHI measured by the Sunrise® medical device and desaturation index measured by ventilatory polygraphy.

Conduct of research

At Strasbourg University Hospital, the study will be proposed to patients admitted for diabetic assessment who require ventilatory polygraphy.
At Mulhouse hospital (GHRMSA), patients are referred to a pneumologist in case of suspected OSAHS and a ventilatory polygraphy is scheduled at home. Patients scheduled to undergo this examination will be invited to take part in the study.

Ventilatory polygraphy (routine care):

Patients included in the study will receive an additional recording using the Sunrise© medical device, performed simultaneously with the ventilatory polygraphy.

Ventilatory polygraphy will be performed in accordance with each center's usual practices. For patients undergoing home polygraphy (GHRMSA), the care team will install the sensors and program the device for recording during sleep. The patient will return home and spend the night there, before coming back to the hospital the following day to give back the equipment. For patients hospitalized in the diabetology department of Strasbourg University Hospital, ventilatory polygraphy will be carried out during hospitalization.

Sunrise© medical device (examination added by research):

The mobile application will be installed on patient's smartphone by the study investigating team, and the use of the Sunrise© device will be explained to the patient. Recording will take place on the same night as the ventilatory polygraphy.

The day after recording, the Sunrise© sensor and ventilatory polygraph equipment will be collected by the investigating team.

Conditions: Obstructive Sleep Apnea Hypopnea Syndrome
Being tested: SUNRISE© device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SUNRISE© deviceDiagnostic test
The device under study is the Sunrise© sensor, a single-use Class IIa medical device with CE marking and ISO 13485 certification.
The system combines a mandibular movement sensor with an artificial intelligence program to collect and interpret data. It consists of a three-gram device that is placed on the chin using an adhesive. The sensor is linked to a (free) mobile app, enabling data to be sent to the Sunrise© company's secured platform at the end of the night, and results to be transmitted to the prescribing physician.

Study groups in NCT06460441
Study group	Role	What they receive
Suspected OSAHS		Not described Receives: Diagnostic Test: SUNRISE© device

What is being measured

The primary outcome is the main question the study is designed to answer.

Apnea-hypopnea index (AHI)
The apnea-hypopnea index (AHI) will be measured using the Sunrise® medical device and ventilatory polygraphy. It corresponds to the number of apnea-hypopnea episodes per hour of sleep.
Measured: Day 1

Secondary outcomes (4)

Dorsal AHI
Measured: Day 1
Non- dorsal AHI
Measured: Day 1
Dorsal Obstructive respiratory disturbance index (ORDI)
Measured: Day 1
Non dorsal ORDI
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jun 202428 Feb 2025

First posted14 Jun 2024
Study start19 Jun 2024
Primary completion28 Feb 2025
Study completion28 Feb 2025

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 Obstructive Sleep Apnea Hypopnea SyndromeStudies 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: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06460441
Sponsor's protocol ID: GHRMSA 1350
Acronym: SUNPV
Status last verified: Apr 2025
First submitted: 11 Jun 2024
Last updated: 29 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Nassurally F, Palpacuer C, Leclercq A, Iamandi C, Renaud-Picard B, Fall-Mostaine F, Debieuvre D, Mohamed R, Meyer L, Kessler L, Kessler R. [Automated analysis of mandibular movements for the screening of obstructive sleep apnea]. Rev Mal Respir. 2026 May 21:S0761-8425(26)00028-8. doi: 10.1016/j.rmr.2026.05.001. Online ahead of print. French.
PubMed 42168007

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

All Obstructive Sleep Apnea Hypopnea Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the SUNRISE© Device With Ventilatory Polygraphy for the Diagnosis of Obstructive Sleep Apnea Hypopnea Syndrome: Collection of Preliminary Data
ClinicalTrials.gov ID: NCT06460441
Acronym / sponsor ID: SUNPV / GHRMSA 1350
Conditions: Obstructive Sleep Apnea Hypopnea Syndrome
Study type: Observational
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud AlsaceUniversity, hospital or other
Collaborators: University Hospital, Strasbourg, France
Study start: 19 Jun 2024 (actual)
Primary completion: 28 Feb 2025 (actual)
Study completion: 28 Feb 2025 (actual)
First posted: 14 Jun 2024 (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.

Detailed description

Secondary objectives

To assess the correlation of the following parameters:

dorsal Apnea-Hypopnea Index (AHI) measured by ventilatory polygraphy and dorsal Obstructive Respiratory Disturbance Index (ORDI) measured by Sunrise® device
non-dorsal AHI measured by ventilatory polygraphy and non-dorsal ORDI measured by Sunrise® device

To study the correlation between AHI measured by the Sunrise® medical device and desaturation index measured by ventilatory polygraphy.

Conduct of research

At Strasbourg University Hospital, the study will be proposed to patients admitted for diabetic assessment who require ventilatory polygraphy.
At Mulhouse hospital (GHRMSA), patients are referred to a pneumologist in case of suspected OSAHS and a ventilatory polygraphy is scheduled at home. Patients scheduled to undergo this examination will be invited to take part in the study.

Ventilatory polygraphy (routine care):

Patients included in the study will receive an additional recording using the Sunrise© medical device, performed simultaneously with the ventilatory polygraphy.

Sunrise© medical device (examination added by research):

The day after recording, the Sunrise© sensor and ventilatory polygraph equipment will be collected by the investigating team.

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Suspected OSAHS	–	Diagnostic Test: SUNRISE© device

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study will be proposed to diabetic patients treated in the diabetology department of the Strasbourg University Hospital, as well as to patients referred to the pneumology consultation at the GHRMSA (Mulhouse) who need to have their sleep disorders investigated using ventilatory polygraphy.

Key inclusion criteria (4 listed)

Patient aged 18 or over;
Patient with a smartphone (Android or iOS) with Bluetooth and Internet connection and able to use the mobile application associated with the Sunrise© medical device;
Patient having a scheduled exploration by ventilatory polygraphy;
Non-opposition to participation in the research.

Key exclusion criteria (6 listed)

Patient suffering from a psychiatric pathology or with a history of behavioral disorders;
Patient already treated for OSAHS;
Patient refusing to cut his beard (if too abundant to wear the Sunrise© device);
Patient suffering from a pathology affecting the rotation of the condyle in the temporomandibular joint;
Patient deprived of liberty by judicial or administrative decision;

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
SUNRISE© deviceThe device under study is the Sunrise© sensor, a single-use Class IIa medical device with CE marking and ISO 13485 certification. The system combines a mandibular movement sensor with an artificial intelligence program to collect and interpret data. It consists of a three-gram device that is placed on the chin using an adhesive. The sensor is linked to a (free) mobile app, enabling data to be sent to the Sunrise© company's secured platform at the end of the night, and results to be transmitted to the prescribing physician.	Diagnostic test	Suspected OSAHS

Primary outcome

Apnea-hypopnea index (AHI)
Time frame: Day 1
The apnea-hypopnea index (AHI) will be measured using the Sunrise® medical device and ventilatory polygraphy. It corresponds to the number of apnea-hypopnea episodes per hour of sleep.

4 secondary outcomes

Dorsal AHI
Time frame: Day 1
Non- dorsal AHI
Time frame: Day 1
Dorsal Obstructive respiratory disturbance index (ORDI)
Time frame: Day 1
Non dorsal ORDI
Time frame: Day 1

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 29 May 2026.
Results publication: PubMed 42168007Nassurally F, Palpacuer C, Leclercq A, Iamandi C, Renaud-Picard B, Fall-Mostaine F, Debieuvre D, Mohamed R, Meyer L, Kessler L, Kessler R. [Automated analysis of mandibular movements for the screening of obstructive sleep apnea]. Rev Mal Respir. 2026 May 21:S0761-8425(26)00028-8. doi: 10.1016/j.rmr.2026.05.001. Online ahead of print. French.

Related trials for Obstructive Sleep Apnea Hypopnea Syndrome

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

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.

The record lists no contact. Use the official record to reach the sponsor.

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 Hypopnea Syndrome, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.

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 6 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 29 May 2026. 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 France. 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 (AHI) (time frame: Day 1). 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 NCT06460441, 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 29 May 2026.