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

NCT ID: NCT02698059

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-22
• Study Completion Date: 2020-05-31

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.

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).

Conditions

Obstructive Sleep Apnea (OSA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treated

iNAP® Sleep Therapy System Treatment

Group Type: EXPERIMENTAL

iNAP® Sleep Therapy System (iNAP)

Intervention Type: 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.

Baseline/Control

Self-controlled, pre-treatment baseline

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

iNAP® Sleep Therapy System (iNAP)

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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).

• 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.

Patients who fulfill all the enrollment criteria of Stage I and whose treated AHI on the 1st Tx PSG Night is below 40.

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Somnics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hartmut Schneider, M.D.

Role: PRINCIPAL_INVESTIGATOR

American Sleep Clinic Frankfurt

Locations

INTERSOM

Cologne, , Germany

Site Status: RECRUITING

Somnolab

Dortmund, , Germany

Site Status: RECRUITING

Alfred Krupp Krankenhaus

Essen, , Germany

Site Status: RECRUITING

American Sleep Clinic

Frankfurt, , Germany

Site Status: RECRUITING

HELIOS Klinik Ambrock

Hagen, , Germany

Site Status: RECRUITING

Krankenhaus Bethanien

Solingen, , Germany

Site Status: RECRUITING

Mackay Memorial Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Germany; Taiwan

Central Contacts

C.C. Chen, Ph.D.

Role: CONTACT

chungchu1@somnics.com

C.N. Huang, Ph.D.

Role: CONTACT

huangcn@somnics.com

Facility Contacts

Lennart Knaack

Role: primary

Hans-Christian Blum

Role: primary

Ricardo Stoohs

Role: primary

Hartmut Schneider

Role: primary

Georg Nilius

Role: primary

Randerath

Role: primary

Ying-Piao Wang

Role: primary

Chia-Mo Lin

Role: primary

References

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.

Reference Type: DERIVED

PMID: 38678757 (View on PubMed)

Other Identifiers

iNAP®-CE-1501

Identifier Type: -

Identifier Source: org_study_id