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Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) Obstructive Sleep Apnea Syndrome (OSAS)

Primary Purpose

Snoring, Obstructive Sleep Apnea

Status
Active
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Implantation
Sponsored by
Medartis AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Snoring focused on measuring Snoring, Obstructive Sleep Apnea

Eligibility Criteria

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

Inclusion Criteria:

  • • Socially disturbing snoring and obstructive sleep apnea syndrome with AHI≥10/h

    • Predominantly retropalatal obstructions established either by:
    • Drug-induced sedation nasendoscopy
    • or ApneaGraph ≥60% (optional)
    • or successful application of the Velumount palatal device (optional)
    • Findings for predominantly retropalatal obstructions in ENT-examination:
    • No tonsils or tonsils grade I
    • Normal finding of larynx and tongue base, no omega-shaped epiglottis
    • No lingual tonsil hypertrophy
    • ASA (American Society of Anaesthesiology, 1963) classes I or II
    • Body mass index (BMI) < 30 kg/m2
    • Age > 18 yrs
    • Fix bed partner
    • Ability to read and understand the patient's information

Exclusion Criteria:

  • • Previous Pillar implants

    • Medartis palatinal implant (from previous phase I study)
    • 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
    • Recurrent tonsillitis with prescription of antibiotics during the last 2 years (≥3x/year)
    • Omega-shaped epiglottis
    • Lingual tonsil hypertrophy
    • Kinking of the internal carotid artery

Sites / Locations

  • Kantonsspital Liestal

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single center, prospective, non-randomized, non-blinded study

Arm Description

Implantation of 6 PPIS implants in each patient

Outcomes

Primary Outcome Measures

AHI reduction
AHI reduction

Secondary Outcome Measures

Full Information

First Posted
October 26, 2017
Last Updated
March 6, 2023
Sponsor
Medartis AG
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1. Study Identification

Unique Protocol Identification Number
NCT03640793
Brief Title
Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) Obstructive Sleep Apnea Syndrome (OSAS)
Official Title
Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) for the Treatment of Snoring and Obstructive Sleep Apnea Syndrome (OSAS): a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 9, 2017 (Actual)
Primary Completion Date
February 13, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) for the Treatment of Snoring and Obstructive Sleep Apnea Syndrome (OSAS): A Pilot Study.
Detailed Description
The clinical study is designed as single center, prospective, non-randomized and non-blinded clinical study. Since the surgical procedure is independent of the population a single center study is applied. A double-blind study is not possible considering the implantation procedure with the surgeon always knowing if the device is set. Therefore, the study is designed to be non-randomized and non-blinded as a pilot trial. To reduce bias and other influences of single surgeon skills a principal investigator and one investigator are part of the clinical study. Further, subjects with previous treatments such as Pillar implant or previous airway surgery other than nasal, adenoid, tonsil or UPPP are excluded from the clinical study. A double-blind study is not possible considering the implantation procedure with the surgeon always knowing if the device is set. Therefore, the study is designed to be non-randomized and non-blinded as a pilot trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snoring, Obstructive Sleep Apnea
Keywords
Snoring, Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single center, prospective, non-randomized, and non-blinded study
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single center, prospective, non-randomized, non-blinded study
Arm Type
Experimental
Arm Description
Implantation of 6 PPIS implants in each patient
Intervention Type
Device
Intervention Name(s)
Implantation
Intervention Description
Implantation of 6 PPIS implants
Primary Outcome Measure Information:
Title
AHI reduction
Description
AHI reduction
Time Frame
3 months post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Socially disturbing snoring and obstructive sleep apnea syndrome with AHI≥10/h Predominantly retropalatal obstructions established either by: Drug-induced sedation nasendoscopy or ApneaGraph ≥60% (optional) or successful application of the Velumount palatal device (optional) Findings for predominantly retropalatal obstructions in ENT-examination: No tonsils or tonsils grade I Normal finding of larynx and tongue base, no omega-shaped epiglottis No lingual tonsil hypertrophy ASA (American Society of Anaesthesiology, 1963) classes I or II Body mass index (BMI) < 30 kg/m2 Age > 18 yrs Fix bed partner Ability to read and understand the patient's information Exclusion Criteria: • Previous Pillar implants Medartis palatinal implant (from previous phase I study) 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 Recurrent tonsillitis with prescription of antibiotics during the last 2 years (≥3x/year) Omega-shaped epiglottis Lingual tonsil hypertrophy Kinking of the internal carotid artery
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
Basel Land
ZIP/Postal Code
4410
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) Obstructive Sleep Apnea Syndrome (OSAS)

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