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

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

Study Overview

• Status: Completed
• Conditions: Reduction of Initial AHI; Reduction of Initial Snoaring Index
• Intervention / Treatment: Device: The IMD is a resilient palatal implant which is introduced through a stab incision into the palate.

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%

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Baselland
    • Basel, Baselland, Switzerland, 4410
      • Kantonsspital Liestal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Study patients must meet all of the following 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 .	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of initial AHI by ≥20%	The primary endpoint is the Apnea-Hypopnea-Index (AHI) at the 90 days follow-up. Study hypothesis: Reduction of initial AHI ≥20%. AHI is measured using cardio-respiratory polygraphy. Two measurements are performed before treatment and at 90 days follow-up in order to reduce effects from night-to-night variability.	90days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of initial snoring index ≥30%	Endpoint snoring is measured on a continuous Visual Analog Scale (VAS) by the bed partner. Study hypothesis: Reduction of initial snoring index ≥30%	90days

Collaborators and Investigators

• Sponsor: Medartis AG
• Investigators: Principal Investigator: Kurt Tschopp, MD, Kantonsspital Liestal

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: March 20, 2014
• First Submitted That Met QC Criteria: March 20, 2014
• First Posted (Estimate): March 21, 2014

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 6, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Respiratory Sounds; Sleep Apnea, Obstructive; Snoring
• Other Study ID Numbers: P08138.1