Prospective Evaluation of a New Palatal… | Clinical Trial

Key information

Conditions

Reduction of Initial AHI Reduction of Initial Snoaring Index

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kantonsspital Liestal

Basel, Basel-Landschaft, 4410, Switzerland

About this study

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%

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

Reduction of initial AHI by ≥20%

Time frame: 90days

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 outcomes

Reduction of initial snoring index ≥30%

Time frame: 90days

Endpoint snoring is measured on a continuous Visual Analog Scale (VAS) by the bed partner.

Study hypothesis: Reduction of initial snoring index ≥30%

Sponsors and collaborators

Lead sponsor

Medartis AG

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2020
Study completion: 2020
First posted: Mar 21, 2014
Registry last updated: Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.