Nasal Airway Stent (Nastent®) Study in OSA (Nastent)

July 29, 2021 updated by: ethisch.comite@uza.be, University Hospital, Antwerp

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Antwerp
      • Edegem, Antwerp, Belgium, 2650
        • Antwerp University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nastent® users
Patients with an established diagnosis of obstructive sleep apnea with apnea/hypopnea-index (AHI) < 20/ hour sleep who receive Nastent® as treatment modality
Device: Nastent® (a distally perforated soft silicon nasal tube)
Insertion of the Nastent® to nostril during sleep hours
Diagnostic test: Polygraphy with WatchPAT™ 300
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.
Other Names:
  • PG

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
At baseline
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)
at follow up after completion of treatment period (an average of three weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Epworth sleepiness scale score (ESS)
Time Frame: baseline
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.)
baseline
VAS (visual analogue scale) for snoring
Time Frame: Baseline
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).
Baseline
ODI (oxygen desaturation index)
Time Frame: baseline
The ODI represents the average number of desaturation episodes (≥3%) per hour sleep.
baseline
PAT (peripheral arterial tone) signal
Time Frame: baseline
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.
baseline
Heart rate
Time Frame: baseline
The number of times a person's heart beats per minute. Normal heart rate range for adults is 60 to 100 beats per minute.
baseline
Body position
Time Frame: baseline
Percentage of supine, prone, left, right, upright position
baseline
Snoring
Time Frame: baseline
Snoring loudness in decibels
baseline
Oxygen saturation (SaO2)
Time Frame: baseline
A measurement of the percentage of how much hemoglobin is saturated with oxygen
baseline
RDI (Respiratory disturbance index)
Time Frame: baseline
Number of apneas, hypopneas and respiratory-effort related arousals (RERAs) per hour of sleep which is an indicator of severity of sleep apnea
baseline
Sleep/wake state
Time Frame: baseline
Percentage of sleep and wake state
baseline
REM sleep
Time Frame: baseline
Percentage of REM sleep
baseline
Deep sleep
Time Frame: baseline
Percentage of deep sleep
baseline
Light sleep
Time Frame: baseline
Percentage of light sleep
baseline
Sleep latency
Time Frame: baseline
Latency of start of sleep in minutes
baseline
REM latency
Time Frame: baseline
Latency of start of REM sleep in minutes
baseline
Total sleep time
Time Frame: baseline
Total sleep time in minutes
baseline
Epworth sleepiness scale score (ESS)
Time Frame: at follow up after completion of treatment period (an average of three weeks)
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.)
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)
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).
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)
The ODI represents the average number of desaturation episodes (≥3%) per hour sleep.
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)
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.
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)
The number of times a person's heart beats per minute. Normal heart rate range for adults is 60 to 100 beats per minute.
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)
Percentage of supine, prone, left, right, upright position
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)
Snoring loudness in decibels
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)
A measurement of the percentage of how much hemoglobin is saturated with oxygen
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)
Number of apneas, hypopneas and respiratory-effort related arousals (RERAs) per hour of sleep which is an indicator of severity of sleep apnea
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)
Percentage of sleep and wake state
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)
Percentage of REM sleep
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)
Percentage of deep sleep
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)
Percentage of light sleep
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)
Latency of start of sleep in minutes
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)
Latency of start of REM sleep in minutes
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)
Total sleep time in minutes
at follow up after completion of treatment period (an average of three weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Antwerp

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Olivier Vanderveken, MD, PhD, Head of ENT department, UZA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B300201942080

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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