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

Primary Purpose

Reduction of Initial AHI, Reduction of Initial Snoaring Index

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
The IMD is a resilient palatal implant which is introduced through a stab incision into the palate.
Sponsored by
Medartis AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reduction of Initial AHI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kantonsspital Liestal

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

OSAS Palatal Implant

Arm Description

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 .

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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%

Full Information

First Posted
March 20, 2014
Last Updated
September 6, 2021
Sponsor
Medartis AG
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1. Study Identification

Unique Protocol Identification Number
NCT02094482
Brief Title
Prospective Evaluation of a New Palatal Implant for Treatment of Snoring and Obstructive Sleep Apnea (OSAS)
Official Title
Prospective Evaluation of a New Palatal Implant for Treatment of Snoring and Obstructive Sleep Apnea (OSAS)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
July 2020 (Actual)
Study Completion Date
October 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medartis AG

4. Oversight

5. Study Description

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%

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reduction of Initial AHI, Reduction of Initial Snoaring Index

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OSAS Palatal Implant
Arm Type
Other
Arm Description
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
Intervention Name(s)
The IMD is a resilient palatal implant which is introduced through a stab incision into the palate.
Intervention Description
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
Primary Outcome Measure Information:
Title
Reduction of initial AHI by ≥20%
Description
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.
Time Frame
90days
Secondary Outcome Measure Information:
Title
Reduction of initial snoring index ≥30%
Description
Endpoint snoring is measured on a continuous Visual Analog Scale (VAS) by the bed partner. Study hypothesis: Reduction of initial snoring index ≥30%
Time Frame
90days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt Tschopp, MD
Organizational Affiliation
Kantonsspital Liestal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspital Liestal
City
Basel
State/Province
Baselland
ZIP/Postal Code
4410
Country
Switzerland

12. IPD Sharing Statement

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

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