Obstructive Sleep ApneaNastentNCT04305964

Nasal Airway Stent (Nastent®) Study in OSA

A study testing Nastent® (a distally perforated soft silicon nasal tube) and Polygraphy with WatchPAT™ 300 in people with Obstructive Sleep Apnea, run by University Hospital, Antwerp at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Obstructive Sleep Apnea
What is being tested?: Nastent® (a distally perforated soft silicon nasal tube) and Polygraphy with WatchPAT™ 300
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteBelgium
Study dates: 1 May 2020to Dec 2021
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 ≥ 18
AHI ≤ 20 per hour of sleep
Complaints of socially disturbing snoring by the partner of the patient
Capable of giving informed consent

Who cannot join

Craniofacial deformities
Acute nasal trauma, fracture (during the past 3 months)
Nasal valve collapse, synechiae and septal perforation, recurrent epistaxis, recent nasopharyngeal surgery, chronic rhinosinusitis with or without polyposis
Cerebrospinal fluid leaks
History of past or current psychiatric disorders (psychotic illness, major depression, or acute anxiety attacks as mentioned by the patient), intellectual disability, memory disorders, seizure disorders, neuromuscular disorders, cardiovascular diseases, coagulopathies (thrombocytopenia< 100/µl), lower respiratory tract disorders.
Pregnancy or willing to become pregnant
Excessive alcohol or drug use (> 20 alcohol units/week or any use of hard drugs)
History of sleep medication use

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Antwerp University Hospital
Edegem, Antwerp, 2650

Other trials in Belgium

About this study

Official title: The Use of Nasal Airway Stent (Nastent®) in Patients With Sleep-disordered Breathing (SDB) Including Snoring and/or Obstructive Sleep Apnea (OSA).

This study intends to assess the effect of nasal airway stent (Nasten®) as a treatment modality in patients with sleep-disordered breathing (SDB) including snoring and/or obstructive sleep apnea (OSA). Nastent®, a distally perforated soft silicon nasal tube, is a mechanical splint against collapse of the upper airway at multiple levels. Nastent® might be able to prevent the vibrations caused by fluttering of various parts of the upper airway which leads to snoring. Furthermore, it also potentially secures a patent airway throughout the night securing airflow.

Read the detailed description

Patients with an established diagnosis of OSA with apnea/hypopnea-index (AHI)< 20/ hour sleep from the ENT department are recruited and informed about the study. After obtaining informed consent and patient inclusion, a baseline portable sleep monitoring at home using WatchPAT™300 for one night is performed. During the next visit the objective size and position of the stent is determined under direct visualization using fiberoptic nasolaryngoscopy. Subsequently, the patients will receive a Nastent® Starter kit (containing 6 different stent sizes of Nastent®, 130, 135, 140, 145, 150 and 155mm) to gradually get accustomed to the stent and to find the right size for them. During the following consultation, a Nastent® classic kit (containing 7 stents of the same size, each can be used for two consecutive nights) is given to the patients to be used for 14 consecutive nights. During the last night of this 14-night period, a follow-up home portable sleep monitoring evaluation using WatchPAT™300 is performed with Nastent® in situ. Afterwards, during the final visit at the outpatient clinic, acceptance of the therapy with Nastent® by the patients is evaluated, and the decision of whether to continue the therapy and to proceed to the purchase of this product as a long-term treatment for the patient or not, is made.

Conditions: Obstructive Sleep Apnea
Being tested: Nastent® (a distally perforated soft silicon nasal tube), Polygraphy with WatchPAT™ 300
Keywords: Obstructive Sleep Apnea, Snoring, Stent
Medical subject headings: Sleep Apnea, Obstructive, Snoring

What participants receive

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

Nastent® (a distally perforated soft silicon nasal tube)Device
Insertion of the Nastent® to nostril during sleep hours
Polygraphy with WatchPAT™ 300Diagnostic test
Also called PG
WatchPAT™ 300 is an innovative diagnostic Home Sleep Apnea Test (HSAT) that utilizes the proprietary Peripheral Arterial Tone signal (PAT™) to enable simple, accurate and reliable sleep apnea testing.

Study groups in NCT04305964
Study group	Role	What they receive
Nastent® users	Experimental	Patients with an established diagnosis of obstructive sleep apnea with apnea/hypopnea-index (AHI) < 20/ hour sleep who receive Nastent® as treatment modality Receives: Device: Nastent® (a distally perforated soft silicon nasal tube); Diagnostic Test: Polygraphy with WatchPAT™ 300

What is being measured

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

AHI (apnea-hypopnea index)
Number of apneas and hypopneas per hour of sleep which is an indicator of severity of sleep apnea, (5< normal, 5-15 Mild, 15-30 moderate, <30 severe)
Measured: At baseline
AHI (apnea-hypopnea index)
Number of apneas and hypopneas per hour of sleep which is an indicator of severity of sleep apnea, (5< normal, 5-15 Mild, 15-30 moderate, <30 severe)
Measured: at follow up after completion of treatment period (an average of three weeks)

Secondary outcomes (32)

Epworth sleepiness scale score (ESS)
an 8-item questionnaire which takes about three minutes to fill out. It reflects the chance of each person's general level of sleepiness during eight situations of daily life. The subject selects the most appropriate integer score ranging from 0 (would never doze) to 3 (high chance of dozing) for each of the 8 questions. The results are then summed up, with 0 being the minimal and 24 the maximum total ESS score. The higher the ESS score, the higher that person's average sleep propensity in daily life. (0-5=Lower Normal Daytime Sleepiness, 6-10 = Higher Normal Daytime Sleepiness, 11-12 = Mild Excessive Daytime Sleepiness, 13-15 = Moderate Excessive Daytime Sleepiness, 16-24 =Severe Excessive Daytime Sleepiness.)
Measured: baseline
VAS (visual analogue scale) for snoring
A standard 10-point VAS ranging from 0 (no snoring) to 10 (extreme snoring causing the bed partner to leave the bedroom or sleep separately) will be used to evaluate the subjective status of snoring during sleep. Heavy snoring corresponds to a snoring index of at least 7. A decrease of 3 points after treatment is considered significant. A satisfactory improvements is defined as a reduction to an index that is no longer experiences as bothersome (i.e. <3).
Measured: Baseline
ODI (oxygen desaturation index)
The ODI represents the average number of desaturation episodes (≥3%) per hour sleep.
Measured: baseline
PAT (peripheral arterial tone) signal
PAT™ technology is a non-invasive window to the cardiovascular system and autonomic nervous system. Peripheral Arterial Tone (PAT™) signal is a proprietary technology used for non-invasively measuring arterial tone changes in peripheral arterial beds.
Measured: baseline
Heart rate
The number of times a person's heart beats per minute. Normal heart rate range for adults is 60 to 100 beats per minute.
Measured: baseline
Body position
Percentage of supine, prone, left, right, upright position
Measured: baseline
Snoring
Snoring loudness in decibels
Measured: baseline
Oxygen saturation (SaO2)
A measurement of the percentage of how much hemoglobin is saturated with oxygen
Measured: baseline
RDI (Respiratory disturbance index)
Number of apneas, hypopneas and respiratory-effort related arousals (RERAs) per hour of sleep which is an indicator of severity of sleep apnea
Measured: baseline
Sleep/wake state
Percentage of sleep and wake state
Measured: baseline
REM sleep
Percentage of REM sleep
Measured: baseline
Deep sleep
Percentage of deep sleep
Measured: baseline
Light sleep
Percentage of light sleep
Measured: baseline
Sleep latency
Latency of start of sleep in minutes
Measured: baseline
REM latency
Latency of start of REM sleep in minutes
Measured: baseline
Total sleep time
Total sleep time in minutes
Measured: baseline
Epworth sleepiness scale score (ESS)
an 8-item questionnaire which takes about three minutes to fill out. It reflects the chance of each person's general level of sleepiness during eight situations of daily life. The subject selects the most appropriate integer score ranging from 0 (would never doze) to 3 (high chance of dozing) for each of the 8 questions. The results are then summed up, with 0 being the minimal and 24 the maximum total ESS score. The higher the ESS score, the higher that person's average sleep propensity in daily life. (0-5=Lower Normal Daytime Sleepiness, 6-10 = Higher Normal Daytime Sleepiness, 11-12 = Mild Excessive Daytime Sleepiness, 13-15 = Moderate Excessive Daytime Sleepiness, 16-24 =Severe Excessive Daytime Sleepiness.)
Measured: at follow up after completion of treatment period (an average of three weeks)
VAS (visual analogue scale) for snoring
A standard 10-point VAS ranging from 0 (no snoring) to 10 (extreme snoring causing the bed partner to leave the bedroom or sleep separately) will be used to evaluate the subjective status of snoring during sleep. Heavy snoring corresponds to a snoring index of at least 7. A decrease of 3 points after treatment is considered significant. A satisfactory improvements is defined as a reduction to an index that is no longer experiences as bothersome (i.e. <3).
Measured: at follow up after completion of treatment period (an average of three weeks)
ODI (oxygen desaturation index)
The ODI represents the average number of desaturation episodes (≥3%) per hour sleep.
Measured: at follow up after completion of treatment period (an average of three weeks)
PAT (peripheral arterial tone) signal
PAT™ technology is a non-invasive window to the cardiovascular system and autonomic nervous system. Peripheral Arterial Tone (PAT™) signal is a proprietary technology used for non-invasively measuring arterial tone changes in peripheral arterial beds.
Measured: at follow up after completion of treatment period (an average of three weeks)
Heart rate
The number of times a person's heart beats per minute. Normal heart rate range for adults is 60 to 100 beats per minute.
Measured: at follow up after completion of treatment period (an average of three weeks)
Body position
Percentage of supine, prone, left, right, upright position
Measured: at follow up after completion of treatment period (an average of three weeks)
Snoring
Snoring loudness in decibels
Measured: at follow up after completion of treatment period (an average of three weeks)
Oxygen saturation (SaO2)
A measurement of the percentage of how much hemoglobin is saturated with oxygen
Measured: at follow up after completion of treatment period (an average of three weeks)
RDI (Respiratory disturbance index)
Number of apneas, hypopneas and respiratory-effort related arousals (RERAs) per hour of sleep which is an indicator of severity of sleep apnea
Measured: at follow up after completion of treatment period (an average of three weeks)
Sleep/wake state
Percentage of sleep and wake state
Measured: at follow up after completion of treatment period (an average of three weeks)
REM sleep
Percentage of REM sleep
Measured: at follow up after completion of treatment period (an average of three weeks)
Deep sleep
Percentage of deep sleep
Measured: at follow up after completion of treatment period (an average of three weeks)
Light sleep
Percentage of light sleep
Measured: at follow up after completion of treatment period (an average of three weeks)
Sleep latency
Latency of start of sleep in minutes
Measured: at follow up after completion of treatment period (an average of three weeks)
REM latency
Latency of start of REM sleep in minutes
Measured: at follow up after completion of treatment period (an average of three weeks)
Total sleep time
Total sleep time in minutes
Measured: at follow up after completion of treatment period (an average of three weeks)

Timeline

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

1 May 2020Dec 2021

First posted12 Mar 2020
Study start1 May 2020
Primary completionDec 2021 (estimated)
Study completionDec 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
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: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04305964
Sponsor's protocol ID: B300201942080
Acronym: Nastent
Status last verified: Jul 2021
First submitted: 3 Mar 2020
Last updated: 30 Jul 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Okuno K, Ono Minagi H, Ikai K, Matsumura Ai E, Takai E, Fukatsu H, Uchida Y, Sakai T. The efficacy of nasal airway stent (Nastent) on obstructive sleep apnoea and prediction of treatment outcomes. J Oral Rehabil. 2019 Jan;46(1):51-57. doi: 10.1111/joor.12725. Epub 2018 Oct 21.
PubMed 30281824
Kumar AR, Guilleminault C, Certal V, Li D, Capasso R, Camacho M. Nasopharyngeal airway stenting devices for obstructive sleep apnoea: a systematic review and meta-analysis. J Laryngol Otol. 2015 Jan;129(1):2-10. doi: 10.1017/S0022215114003119. Epub 2014 Dec 29.
PubMed 25544266

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 trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Use of Nasal Airway Stent (Nastent®) in Patients With Sleep-disordered Breathing (SDB) Including Snoring and/or Obstructive Sleep Apnea (OSA).
ClinicalTrials.gov ID: NCT04305964
Acronym / sponsor ID: Nastent / B300201942080
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea, Snoring, Stent
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 4 participants (actual)
Lead sponsor: University Hospital, AntwerpUniversity, hospital or other
Study start: 1 May 2020 (actual)
Primary completion: Dec 2021 (estimated)
Study completion: Dec 2021 (estimated)
First posted: 12 Mar 2020 (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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Nastent® users	Experimental	Device: Nastent® (a distally perforated soft silicon nasal tube), Diagnostic Test: Polygraphy with WatchPAT™ 300Patients with an established diagnosis of obstructive sleep apnea with apnea/hypopnea-index (AHI) < 20/ hour sleep who receive Nastent® as treatment modality

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 ≥ 18
AHI ≤ 20 per hour of sleep
Complaints of socially disturbing snoring by the partner of the patient
Capable of giving informed consent

Key exclusion criteria (8 listed)

Craniofacial deformities
Acute nasal trauma, fracture (during the past 3 months)
Nasal valve collapse, synechiae and septal perforation, recurrent epistaxis, recent nasopharyngeal surgery, chronic rhinosinusitis with or without polyposis
Cerebrospinal fluid leaks
History of past or current psychiatric disorders (psychotic illness, major depression, or acute anxiety attacks as mentioned by the patient), intellectual disability, memory disorders, seizure disorders, neuromuscular disorders, cardiovascular diseases, coagulopathies (thrombocytopenia< 100/µl), lower respiratory tract 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
Nastent® (a distally perforated soft silicon nasal tube)Insertion of the Nastent® to nostril during sleep hours	Device	Nastent® users
Polygraphy with WatchPAT™ 300Also: PGWatchPAT™ 300 is an innovative diagnostic Home Sleep Apnea Test (HSAT) that utilizes the proprietary Peripheral Arterial Tone signal (PAT™) to enable simple, accurate and reliable sleep apnea testing.	Diagnostic test	Nastent® users

Primary outcome

AHI (apnea-hypopnea index)
Time frame: At baseline
Number of apneas and hypopneas per hour of sleep which is an indicator of severity of sleep apnea, (5< normal, 5-15 Mild, 15-30 moderate, <30 severe)
AHI (apnea-hypopnea index)
Time frame: at follow up after completion of treatment period (an average of three weeks)
Number of apneas and hypopneas per hour of sleep which is an indicator of severity of sleep apnea, (5< normal, 5-15 Mild, 15-30 moderate, <30 severe)

32 secondary outcomes

Epworth sleepiness scale score (ESS)
Time frame: baseline
VAS (visual analogue scale) for snoring
Time frame: Baseline
ODI (oxygen desaturation index)
Time frame: baseline
PAT (peripheral arterial tone) signal
Time frame: baseline
Heart rate
Time frame: baseline
Body position
Time frame: baseline
Snoring
Time frame: baseline
Oxygen saturation (SaO2)
Time frame: baseline
RDI (Respiratory disturbance index)
Time frame: baseline
Sleep/wake state
Time frame: baseline
REM sleep
Time frame: baseline
Deep sleep
Time frame: baseline
Light sleep
Time frame: baseline
Sleep latency
Time frame: baseline
REM latency
Time frame: baseline
Total sleep time
Time frame: baseline
Epworth sleepiness scale score (ESS)
Time frame: at follow up after completion of treatment period (an average of three weeks)
VAS (visual analogue scale) for snoring
Time frame: at follow up after completion of treatment period (an average of three weeks)
ODI (oxygen desaturation index)
Time frame: at follow up after completion of treatment period (an average of three weeks)
PAT (peripheral arterial tone) signal
Time frame: at follow up after completion of treatment period (an average of three weeks)
Heart rate
Time frame: at follow up after completion of treatment period (an average of three weeks)
Body position
Time frame: at follow up after completion of treatment period (an average of three weeks)
Snoring
Time frame: at follow up after completion of treatment period (an average of three weeks)
Oxygen saturation (SaO2)
Time frame: at follow up after completion of treatment period (an average of three weeks)
RDI (Respiratory disturbance index)
Time frame: at follow up after completion of treatment period (an average of three weeks)
Sleep/wake state
Time frame: at follow up after completion of treatment period (an average of three weeks)
REM sleep
Time frame: at follow up after completion of treatment period (an average of three weeks)
Deep sleep
Time frame: at follow up after completion of treatment period (an average of three weeks)
Light sleep
Time frame: at follow up after completion of treatment period (an average of three weeks)
Sleep latency
Time frame: at follow up after completion of treatment period (an average of three weeks)
REM latency
Time frame: at follow up after completion of treatment period (an average of three weeks)
Total sleep time
Time frame: at follow up after completion of treatment period (an average of three weeks)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
Background: PubMed 30281824Okuno K, Ono Minagi H, Ikai K, Matsumura Ai E, Takai E, Fukatsu H, Uchida Y, Sakai T. The efficacy of nasal airway stent (Nastent) on obstructive sleep apnoea and prediction of treatment outcomes. J Oral Rehabil. 2019 Jan;46(1):51-57. doi: 10.1111/joor.12725. Epub 2018 Oct 21.
Background: PubMed 25544266Kumar AR, Guilleminault C, Certal V, Li D, Capasso R, Camacho M. Nasopharyngeal airway stenting devices for obstructive sleep apnoea: a systematic review and meta-analysis. J Laryngol Otol. 2015 Jan;129(1):2-10. doi: 10.1017/S0022215114003119. Epub 2014 Dec 29.
Individual participant dataSharing planned: No

Related trials for Obstructive Sleep Apnea

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)
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Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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RecruitingPhase 1/2
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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.

Olivier Vanderveken, MD, PhD study chair

Head of ENT department, UZA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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 30 Jul 2021. 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 Belgium. 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?

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?

AHI (apnea-hypopnea index) (time frame: At baseline). 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?

On the ClinicalTrials.gov record for NCT04305964, which also lists 2 linked publications.

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 30 Jul 2021.