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

NCT02094482 | Completed

• 1 other identifier: P08138.1
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Reduction of Initial AHI; Reduction of Initial Snoaring Index

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Reduction of initial snoring index ≥30%

  90days

Study Arms (1)

OSAS Palatal Implant

OTHER

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 .

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

Interventions

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

OSAS Palatal Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medartis AG: lead

Study Sites (1)

Kantonsspital Liestal

Basel, Basel-Landschaft, 4410, Switzerland

Location

Study Officials

• Kurt Tschopp, MD

  Kantonsspital Liestal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: March 21, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2020
• Study Completion: October 1, 2020
• Last Updated: September 13, 2021

Record last verified: 2021-09

Locations

CH (1)