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

Reduction of Initial AHI Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02094482
• Other study ID #: P08138.1
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: October 2020

Study information

• Verified date: September 2021
• Source: Medartis AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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%

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Reduction of Initial AHI
• Reduction of Initial Snoaring Index
• Sleep Apnea, Obstructive
• Snoring

Intervention

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

Locations

Country	Name	City	State
Switzerland	Kantonsspital Liestal	Basel	Baselland

Sponsors (1)

Lead Sponsor	Collaborator
Medartis AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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