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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-09

Study Completion Date

2024-03-04

Brief Summary

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Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) for the Treatment of Snoring and Obstructive Sleep Apnea Syndrome (OSAS): A Pilot Study.

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Detailed Description

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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.

Conditions

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Snoring Obstructive Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Implantation of 6 PPIS implants in each patient

Group Type EXPERIMENTAL

Implantation

Intervention Type DEVICE

Implantation of 6 PPIS implants

Interventions

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Implantation

Implantation of 6 PPIS implants

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No