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Obstructive Sleep Apnea (OSA)NCT02698059

A Post-marketing Surveillance of the Negative Pressure Sleep Therapy System to Treat Obstructive Sleep Apnea

A study testing iNAP® Sleep Therapy System (iNAP) in people with Obstructive Sleep Apnea (OSA), run by Somnics, Inc. at 8 sites in 2 countries.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a post-marketing surveillance study to investigate the efficacy and safety of the Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obstructive Sleep Apnea (OSA)
What is being tested?
iNAP® Sleep Therapy System (iNAP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
8 sitesin 2 countries
Study dates
22 Jan 2016to May 2020
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1) Female or male adults with age between 18~65 years old. (S1)
  • 2) Non-obese patients with body mass index (BMI) <29 kg/m2. (S1)
  • 3) Patients able to read and sign on the informed consent form and able to comply with study requirements. (S1)
  • 4) Patients able to be properly fitted* with the oral interface as observed by the device feasibility test. (S1)
  • 5) Patients with oxygen desaturation index (ODI) between 10~40 (S2).
  • 6) Patients with oral negative vacuum time maintained* by iNAP® ≥4 hours/night and total sleep time (TST) ≥4 hours/night (S3).
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  • iNAP® pressure more negative than -30 mmHg will be considered evidence of effective oral appliance application.
  • 7) Patients with apnea-hypopnea index (AHI) between 10~40 and TST ≥4 hours/night (Baseline PSG Night).
  • 8) Patients with oral negative vacuum time maintained* by iNAP® ≥4 hours/night and TST ≥4 hours/night (1st Tx PSG Night).
  • iNAP® pressure more negative than -30 mmHg will be considered evidence of effective oral appliance application.

Who cannot join

  • 1) Patients who are allergic to silicone.
  • 2) Patients with obstructed nasal passages as evidenced by the inability to breathe through the nose with the mouth closed.
  • 3) Patients who recently experienced a near-miss or prior automobile accident due to sleepiness.
  • 4) Patients who have or have had hypoxemia (SpO2 <80%) in the past six months caused by diseases other than OSA such as cardiac disease or severe pulmonary/respiratory disorders such as chronic obstructive pulmonary disease (COPD), interstitial lung disease, pneumothorax, pneumonia, etc.
  • 5) Female patients who are lactating, pregnant or intend to become pregnant during the study period.
  • 6) Patients with primary insomnia or any concomitant diagnosed or suspected sleep disorder.
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  • 7) Patients with muscle disease, central nervous disease or chronic neurological disorders, including central sleep apnea*.
  • Central sleep apnea is defined as a central apnea index (CAI) ≥ 5/hr or if central sleep apnea accounts for ≥ 50% of the total AHI.
  • 8) Patients in whom it is not suitable to use iNAP® in the opinion of the Investigator including, but not limited to, alcohol or substance abuse, loose teeth, missing teeth, or grinding teeth, completed deviated septum (Type IV or VII) or completed closed nostrils or advanced periodontal disease or tonsillar volumes greater than grade 3.
  • 9) Patients with an inability to sleep through the night including, but not limited to, menopausal hot flashes, working at nights or rotating night shifts, planned travel across four or more time zones during the study period or within one week prior to study participation, or a sleep schedule not compatible with study site practices.
  • 10) Patients with potential complications of sleep apnea that, in the opinion of the Investigator, may affect the study interpretation or the health or safety of the patients including, but not limited to, narcolepsy, restless leg syndrome, nasopharyngeal carcinoma (NPC), end stage renal failure, a history of severe cardiovascular disease (including New York Heart Association (NYHA) class III or IV cardiac failure, coronary artery disease with angina or myocardial infarction/stroke in the past six months, uncontrolled hypertension or hypotension or cardiac arrhythmias), unstable heart or renal transplantation or use of medicine or other treatment(s) that may confound the result of the study or pose additional risks to the patient, such as oral anticoagulants or other agents making patients prone to tongue hemorrhage.
  • Stage II Inclusion Criteria:
  • Patients who fulfill all the enrollment criteria of Stage I and whose treated AHI on the 1st Tx PSG Night is below 40.

Trial locations and contacts

8 sites in 2 countries.

C.C. Chen, Ph.D. contact

chungchu1@somnics.com

C.N. Huang, Ph.D. contact

huangcn@somnics.com

8 sites in 2 countries

Germany6 sites, 6 recruiting

  • INTERSOM

    Cologne

    Lennart Knaack

    Recruiting

  • Somnolab

    Dortmund

    Hans-Christian Blum

    Recruiting

  • Alfred Krupp Krankenhaus

    Essen

    Ricardo Stoohs

    Recruiting

  • American Sleep Clinic

    Frankfurt

    Hartmut Schneider

    Recruiting

  • HELIOS Klinik Ambrock

    Hagen

    Georg Nilius

    Recruiting

  • Krankenhaus Bethanien

    Solingen

    Randerath

    Recruiting

Other trials in Germany

Taiwan2 sites, 2 recruiting

  • Mackay Memorial Hospital

    Taipei, 104

    Ying-Piao Wang

    Recruiting

  • Shin Kong Wu Ho-Su Memorial Hospital

    Taipei, 111

    Chia-Mo Lin

    Recruiting

Other trials in Taiwan

About this study

Official title: A Multi-center, Two-stage, Single-arm, Prospective, First-night Order Cross-over, Evaluator-blind Study to Evaluate the Efficacy, Safety and Tolerance of the iNAP® Sleep Therapy System in Adults With Obstructive Sleep Apnea (OSA)

This is a post-marketing surveillance study to investigate the efficacy and safety of the Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.

Read the detailed description

This is a multi-center, two-stage, single-arm, prospective, first-night order cross-over, evaluator-blind, post-marketing surveillance study to evaluate the efficacy, safety and tolerance of the iNAP® Sleep Therapy System (iNAP), a tongue and soft palate retaining intraoral device, in adults with obstructive sleep apnea (OSA).

Being tested
iNAP® Sleep Therapy System (iNAP)
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.

  • iNAP® Sleep Therapy System (iNAP)Device

    The iNAP provides pressure gradient within the oral cavity to pull the tongue toward upper palate and the soft palate forward, which aims to maintain better upper airway patency near the pharynx to prevent sleep-disordered breathing.

Study groups in NCT02698059
Study groupRoleWhat they receive
TreatedExperimentaliNAP® Sleep Therapy System Treatment
Receives: Device: iNAP® Sleep Therapy System (iNAP)
Baseline/ControlNo interventionSelf-controlled, pre-treatment baseline

What is being measured

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

  1. Clinical success rate* of apnea-hypopnea index (AHI)** on the 1st Tx PSG Night when compared to the Baseline PSG Night.

    *Clinical success rate is defined as the ratio of the number of patients with an AHI reduction of >50% and treated AHI <20 to the number of patients who complete the 1st Tx PSG Night, where completion is defined as a total sleep time (TST) and device negative pressure maintenance ≥4 hours/night on the 1st Tx PSG Night. For completion of the Baseline PSG Study, a total sleep time (TST) ≥4 hours/night has to be met.

    **AHI is the number of apnea/hypopnea events divided by total sleep time (TST), i.e., the number of hours of sleep.

    Measured: first treatment night

Secondary outcomes (3)

  1. AE/SAE rate and type

    Vital signs, Physical examination (PE) findings and change of body figure indexes, Electrocardiogram (ECG) findings as reflected in polysomnography (PSG), Adverse events (AEs), Serious adverse events (SAEs), Changes in the oral and dental condition

    Measured: The whole study period through study completion; up to 8 weeks

  2. Clinical success rate* of apnea-hypopnea index (AHI)** on the 2nd Tx PSG Night when compared to the 1st Tx PSG Night.

    *Clinical success rate is defined as the ratio of the number of patients with an AHI reduction of >50% and treated AHI <20 to the number of patients who complete the 2nd Tx PSG Night, where completion is defined as a total sleep time (TST) and device negative pressure maintenance ≥4 hours/night on the 2nd Tx PSG Night. For completion of the Baseline PSG Study, a total sleep time (TST) ≥4 hours/night has to be met.

    **AHI is the number of apnea/hypopnea events divided by total sleep time (TST), i.e., the number of hours of sleep.

    Measured: second treatment night

  3. Change of Oxygen Desaturation Index (ODI)* from the Baseline PSG Night compared to the 1st Tx PSG Night and the 2nd Tx PSG Night; and the change from the 1st Tx PSG Night compared to the 2nd Tx PSG Night.

    *ODI is the event number of oxygen level drops by 3 percent or more from baseline divided by total sleep time (TST), i.e., the number of hours of sleep.

    Measured: At the Baseline PSG Night, the 1st Tx PSG Night and/or the 2nd Tx PSG Night

Timeline

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

  1. First posted3 Mar 2016 (estimated)
  2. Study start22 Jan 2016
  3. Primary completion18 Feb 2020
  4. Study completionMay 2020 (estimated)

Resources

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
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02698059
Sponsor's protocol ID
iNAP®-CE-1501
Status last verified
Mar 2020
First submitted
17 Feb 2016
Last updated
18 Mar 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Nilius G, Farid-Moayer M, Lin CM, Knaack L, Wang YP, Dellweg D, Stoohs R, Ficker J, Randerath W, Specht MB, Galetke W, Schneider H; iNAP Study Group. Multi-center safety and efficacy study of a negative-pressure intraoral device in obstructive sleep apnea. Sleep Med. 2024 Jul;119:139-146. doi: 10.1016/j.sleep.2024.04.015. Epub 2024 Apr 17.

    PubMed 38678757

Questions about this trial

What is this clinical trial studying?

A study testing iNAP® Sleep Therapy System (iNAP) in people with Obstructive Sleep Apnea (OSA), run by Somnics, Inc. at 8 sites in 2 countries.

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 10 inclusion and 13 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 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Germany, Taiwan. 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?

Contact C.C. Chen, Ph.D. (chungchu1@somnics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical success rate* of apnea-hypopnea index (AHI)** on the 1st Tx PSG Night when compared to the Baseline PSG Night. (time frame: first treatment night). 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 NCT02698059, 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 18 Mar 2020.

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