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

NCT02698059 | Unknown

• 1 other identifier: iNAP®-CE-1501
• Study Type: interventional
• Target: 63
• Locations: 2 countries
• Sites: 8

Brief 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.

Conditions

Obstructive Sleep Apnea (OSA)

Outcome Measures

Primary Outcomes (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.

  first treatment night

Secondary Outcomes (3)

• AE/SAE rate and type

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

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

  second treatment night

• 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.

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

Study Arms (2)

Treated

EXPERIMENTAL

iNAP® Sleep Therapy System Treatment

Device: iNAP® Sleep Therapy System (iNAP)

Baseline/Control

NO INTERVENTION

Self-controlled, pre-treatment baseline

Interventions

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.

Treated

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \) Patients who are allergic to silicone.
• \) Patients with obstructed nasal passages as evidenced by the inability to breathe through the nose with the mouth closed.
• \) Patients who recently experienced a near-miss or prior automobile accident due to sleepiness.
• \) 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.
• \) Female patients who are lactating, pregnant or intend to become pregnant during the study period.
• \) Patients with primary insomnia or any concomitant diagnosed or suspected sleep disorder.
• \) 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.
• \) 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.
• \) 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.
• \) 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.
• Patients who fulfill all the enrollment criteria of Stage I and whose treated AHI on the 1st Tx PSG Night is below 40.

Sponsors & Collaborators

• Somnics, Inc.: lead

Study Sites (8)

INTERSOM

Cologne, Germany

RECRUITING

Somnolab

Dortmund, Germany

RECRUITING

Alfred Krupp Krankenhaus

Essen, Germany

RECRUITING

American Sleep Clinic

Frankfurt, Germany

RECRUITING

HELIOS Klinik Ambrock

Hagen, Germany

RECRUITING

Krankenhaus Bethanien

Solingen, Germany

RECRUITING

Mackay Memorial Hospital

Taipei, 104, Taiwan

RECRUITING

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 38678757 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Hartmut Schneider, M.D.

  American Sleep Clinic Frankfurt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

C.C. Chen, Ph.D.

CONTACT

chungchu1@somnics.com

C.N. Huang, Ph.D.

CONTACT

huangcn@somnics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: March 3, 2016
• Study Start: January 22, 2016
• Primary Completion: February 18, 2020
• Study Completion: May 1, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2); DE (6)