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

Obstructive Sleep Apnea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03640793
• Other study ID #: P15214
• Status: Completed
• Phase: N/A
• Start date: October 9, 2017
• Est. completion date: March 4, 2024

Study information

• Verified date: March 2024
• Source: Medartis AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 4, 2024
• Est. primary completion date: February 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Snoring

Intervention

Device:
• Implantation
Implantation of 6 PPIS implants

Locations

Country	Name	City	State
Switzerland	Kantonsspital Liestal	Basel	Basel Land

Sponsors (1)

Lead Sponsor	Collaborator
Medartis AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AHI reduction	AHI reduction	3 months post-op