SnoringNCT03510403
Efficacy, Safety and Acceptability of Nastent™ in Snoring and Obstructive Sleep Apnea
A study testing nastent™ in people with Snoring and Obstructive Sleep Apnea, run by Seven Dreamers Europe SAS at 6 sites in France.
Trial summary
This study evaluates the efficacy, the tolerance and the acceptability/compliance of the nasal airway stent, Nastent, for the treatment of mild to moderate OSA and snoring in European adult patients without cardiovascular and/or respiratory comorbidities/disorders. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Snoring, Obstructive Sleep Apnea
- What is being tested?
- nastent™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 6 sitesFrance
- Study dates
- 12 Apr 2018to 25 Jul 2019
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject with newly diagnosed OSA (5≤AHI≤30 ev/h) or for whom treatment has failed (CPAP, mandibular repositioning device), or patients with snoring only (5<AHI)
- BMI≤30kg/m²
- Patient with good motivation to use the nasal device,
- Informed consent signed,
- Patient with social protection.
Who cannot join
- Cardiovascular comorbidities (resistant hypertension, recurrent atrial fibrillation, left ventricular failure, coronary heart disease and stroke),
- Respiratory comorbidities (respiratory failure, chronic obstructive pulmonary disease (COPD),
- Patient with one or more documented contraindication to use Nastent™,
- no regular partner,
- contraindication for sleep endoscopy,
- Psychiatric or neurological disorders (epilepsy),
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- Progressive cancer or chronic inflammatory disease,
- AHI including more than 5 central apnea per hour,
- Allergy to one component of Nastent™.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Cabinet ORL de Bordeaux
Bordeaux, 33000
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010
Henri-Mondor Hospital
Créteil, 94010
Beau-Soleil Private Hospital
Montpellier, 34070
Centre Médical Veille Sommeil
Paris, 75017
Foch Hospital
Suresnes, 92151
About this study
Official title: Prospective Non-comparative Study to Assess the Efficacy, the Safety and the Acceptability of Nastent™ in Snoring and Obstructive Sleep Apnea Syndrome in European Population
This study evaluates the efficacy, the tolerance and the acceptability/compliance of the nasal airway stent, Nastent, for the treatment of mild to moderate OSA and snoring in European adult patients without cardiovascular and/or respiratory comorbidities/disorders.
- Conditions
- Snoring, Obstructive Sleep Apnea
- Being tested
- nastent™
- Medical subject headings
- Snoring, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nastent™Device
Snorer and OSA patients (mild or moderate OSA) use the nasal airway stent for sleeping, each night for 1 month.
| Study group | Role | What they receive |
|---|---|---|
| Device : nasal airway stent | Experimental | Patients with OSA or snoring use the nasal airway stent nastent™ each night for sleeping. The device is a tube-shaped medical device that is inserted from the nose and the tip of the tube reaches the soft palate. The inserted tube aids breathing by preventing the obstruction of the airway which causes poor sleep, frequent awakening during sleep and snoring. Receives: Device: nastent™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy : change from baseline Snoring Intensity at 1 month
The snoring intensity will be evaluated by bed-partner of snorers and OSA patients using a Visual Analogue Scale (0-100 mm) at baseline and after 1 month of nastent™ use to assess the efficacy of treatment.
Measured: 1 month
Efficacy : Change from baseline Apnea Hypopnea Index (AHI) at 1 month
The Apnea Hypopnea Index (number of apnea and hypopnea per hour) will be measured by respiratory polygraph on OSA patients subgroup at baseline and after 1 month of nastent™ use to assess the efficacy of treatment.
Measured: 1 month
Secondary outcomes (6)
Change from baseline Sleepiness at 1 month
The Epworth Sleepiness Scale (ESS) will be completed by OSA patients at baseline and after 1 month of nastent™ use to assess the evolution of somnolence/daytime sleepiness. Total score ranges between 0 and 24. A score above 10 indicates excessive daytime sleepiness.
Measured: 1 month
Change from baseline Nasal Obstruction at 1 month
The NOSE questionnaire will be completed by snorers and OSA patients at baseline and after 1 month of nastent™ use to assess the efficacy of the device on the nasal obstruction.Total score ranges between 0 and 100.
Measured: 1 month
Observance
The number of hours of Nastent™ use per night, the number of nights per week will be measured to assess the observance and compliance of the treatment in snorers and OSA patients during one month.
Measured: 1 month
Adverse Events [Safety and Tolerability]
Adverse events reported by patient on a diary (from day 1 to day 30) and clinically observed by the physician will assess the safety and tolerability of the device.
Measured: 1 month
Quality of Life using Functional Outcomes of Sleep Questionnaire (FOSQ-10)
FOSQ-10 measures functional status and difficulty in performing everyday activities via 10 questions. The questionnaire will be completed by snorer and OSA patients at baseline and after 1 month of nastent™ use to assess the evolution of the quality of life. Total score ranges between 5 and 20. Higher scores indicate better functional status.
Measured: 1 month
Physician satisfaction
The physician's global satisfaction with nastent™ efficacy and safety will be assessed for each patient using a numeric scale after one month of treatment. Score ranges between 0 and 10.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start12 Apr 2018
- Primary completion25 Jul 2019
- Study completion25 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SnoringStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seven Dreamers Europe SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Slb Pharma, nastent.inc
- Responsible party
- Sponsor
- Investigators
- Marc Blumen, MD, Principal investigator, Foch Hospital, Suresnes, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510403
- Sponsor's protocol ID
- NASTENT-17-FR
- Status last verified
- Aug 2019
- First submitted
- 3 Apr 2018
- Last updated
- 26 Aug 2019
- 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 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Non-comparative Study to Assess the Efficacy, the Safety and the Acceptability of Nastent™ in Snoring and Obstructive Sleep Apnea Syndrome in European Population
- ClinicalTrials.gov ID
- NCT03510403
- Acronym / sponsor ID
- NASTENT-17-FR
- Conditions
- Snoring, Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Seven Dreamers Europe SASIndustry (pharma, biotech, devices)
- Collaborators
- Slb Pharma, nastent.inc
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 25 Jul 2019 (actual)
- Study completion
- 25 Jul 2019 (actual)
- First posted
- 27 Apr 2018 (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.
This study evaluates the efficacy, the tolerance and the acceptability/compliance of the nasal airway stent, Nastent, for the treatment of mild to moderate OSA and snoring in European adult patients without cardiovascular and/or respiratory comorbidities/disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device : nasal airway stent | Experimental | Device: nastent™Patients with OSA or snoring use the nasal airway stent nastent™ each night for sleeping. The device is a tube-shaped medical device that is inserted from the nose and the tip of the tube reaches the soft palate. The inserted tube aids breathing by preventing the obstruction of the airway which causes poor sleep, frequent awakening during sleep and snoring. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject with newly diagnosed OSA (5≤AHI≤30 ev/h) or for whom treatment has failed (CPAP, mandibular repositioning device), or patients with snoring only (5<AHI)
- BMI≤30kg/m²
- Patient with good motivation to use the nasal device,
- Informed consent signed,
- Patient with social protection.
Key exclusion criteria (9 listed)
- Cardiovascular comorbidities (resistant hypertension, recurrent atrial fibrillation, left ventricular failure, coronary heart disease and stroke),
- Respiratory comorbidities (respiratory failure, chronic obstructive pulmonary disease (COPD),
- Patient with one or more documented contraindication to use Nastent™,
- no regular partner,
- contraindication for sleep endoscopy,
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 |
|---|---|---|
| nastent™Snorer and OSA patients (mild or moderate OSA) use the nasal airway stent for sleeping, each night for 1 month. | Device | Device : nasal airway stent |
Primary outcome
Efficacy : change from baseline Snoring Intensity at 1 month
Time frame: 1 month
The snoring intensity will be evaluated by bed-partner of snorers and OSA patients using a Visual Analogue Scale (0-100 mm) at baseline and after 1 month of nastent™ use to assess the efficacy of treatment.
Efficacy : Change from baseline Apnea Hypopnea Index (AHI) at 1 month
Time frame: 1 month
The Apnea Hypopnea Index (number of apnea and hypopnea per hour) will be measured by respiratory polygraph on OSA patients subgroup at baseline and after 1 month of nastent™ use to assess the efficacy of treatment.
6 secondary outcomes
Change from baseline Sleepiness at 1 month
Time frame: 1 month
Change from baseline Nasal Obstruction at 1 month
Time frame: 1 month
Observance
Time frame: 1 month
Adverse Events [Safety and Tolerability]
Time frame: 1 month
Quality of Life using Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Time frame: 1 month
Physician satisfaction
Time frame: 1 month
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 26 Aug 2019.
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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.
Marc Blumen, MD principal investigator
Foch Hospital, Suresnes, FRANCE
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nastent™ in people with Snoring and Obstructive Sleep Apnea, run by Seven Dreamers Europe SAS at 6 sites 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 5 inclusion and 9 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 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Efficacy : change from baseline Snoring Intensity at 1 month (time frame: 1 month). The study lists 2 primary outcomes in all. 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 26 Aug 2019.