Prospective Evaluation of a New Palatal Implant for Treatment of Snoring and Obstructive Sleep Apnea (OSAS)

NCT ID: NCT02094482

Last Updated: 2021-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2020-10-31

Brief Summary

Prospective Evaluation of a New Palatal Implant for Treatment of Snoring and Obstructive Sleep Apnea (OSAS)

Detailed Description

The new OSAS Implant is intended for use in the palate (hard and soft palate/ see picture above) in order to stiffen and stabilize the soft palate, which may reduce the severity of airway obstructions and of snoring in patients suffering from OSA (Obstructive Sleep Apnea). Indications for use of the System include: symptomatic, habitual, social snoring due to palatal flutter or upper airway obstruction primarily caused by the retropalatal obstruction. The System is labeled for use by physicians only.

The primary endpoint is the Apnea-Hypopnea-Index (AHI) in the 90 days follow-up.

Study hypothesis: Reduction of initial AHI ≥20%

Conditions

Reduction of Initial AHI; Reduction of Initial Snoaring Index

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OSAS Palatal Implant

The IMD is a resilient palatal implant which is introduced through a stab incision into the palate. Two implants are placed underneath the rostral part of the palatal bone and continue into the upper part of the soft palate .

Group Type: OTHER

The IMD is a resilient palatal implant which is introduced through a stab incision into the palate.

Intervention Type: DEVICE

The IMD is a resilient palatal implant which is introduced through a stab incision into the palate. Two implants are placed underneath the rostral part of the palatal bone and continue into the upper part of the soft palate

Interventions

The IMD is a resilient palatal implant which is introduced through a stab incision into the palate.

The IMD is a resilient palatal implant which is introduced through a stab incision into the palate. Two implants are placed underneath the rostral part of the palatal bone and continue into the upper part of the soft palate

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Socially disturbing snoring with/without obstructive sleep apnea syndrome
• Predominantly retropalatal obstructions established by ApneaGraph ≥60%, sleep nasendoscopy or successful application of the Velumount palatal device
• Findings for predominantly retropalatal obstructions in ENT-examination:
• No tonsils or tonsils grade I - II
• Normal finding of larynx and tongue base
• No lingual tonsil hypertrophy
• ASA (American Society of Anaesthesiology, 1963) criteria I or II
• Body mass index (BMI) < 33 kg/m2
• Age > 18 yrs
• Fix bed partner
• Ability to read and understand the patient's information

Exclusion Criteria

• Previous Pillar implants
• Previous airway surgery other than nasal, adenoid, tonsil or UPPP
• Presence of other sleep disorders
• Psychiatric disorders
• Neurological disorders (e.g. Cerebrovascular injury)
• Dysmorphia of the cranial skeleton
• Pregnancy or breastfeeding
• Known hypersensitivity to nitinol
• Participation in another clinical study

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

Sponsors

Medartis AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kurt Tschopp, MD

Role: PRINCIPAL_INVESTIGATOR

Kantonsspital Liestal

Locations

Kantonsspital Liestal

Basel, Basel-Landschaft, Switzerland

Countries

Switzerland

Other Identifiers

P08138.1

Identifier Type: -

Identifier Source: org_study_id