Tongue Advancement for Obstructive Sleep Apnea

Sleep Apnea, Obstructive Clinical Trial

Official title:

Tongue Advancement for Obstructive Sleep Apnea. An Evaluation fo the Aspire Medical Advance System.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00490984
• Other study ID #: TAS 001
• Status: Completed
• Phase: N/A
• First received: June 21, 2007
• Last updated: December 22, 2009
• Start date: February 2006
• Est. completion date: July 2009

Study information

• Verified date: April 2009
• Source: Aspire Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to assess the feasibility, safety and effectiveness of tongue stabilization using Aspire Medical Advance™ System for the treatment of obstructive sleep apnea (OSA). Success is defined as a statistically significant reduction in AHI measured by polysomnography (PSG) from baseline to 6 months.

Description:

Obstructive sleep apnea (OSA) is a major health problem in the United States and can result in excessive daytime sleepiness and cardiovascular problems. The primary treatment for OSA today is continuous positive airway pressure (CPAP). Many patients however are unable to tolerate sleeping with a CPAP machine. Surgery is one of the main treatment options available today to these CPAP-intolerant patients. However, current methods of sleep surgery are painful, morbid, and/or lack decent effectiveness.

This trial will measure the effectiveness of the Advance System, an implantable medical device to treat OSA. In the trial, patients who meet the study entry criteria receive a baseline sleep study (PSG). The Advance System is then implanted and 6 months after implantation, another PSG is performed. The trial will compare the baseline and the 6 month apnea-hypopnea indices

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Documented diagnosis of obstructive sleep apnea with AHI 15-50 measured within a year prior to enrollment with no major change in BMI

• Bewteen 20 and 65 years old

• Body Mass Index (BMI) = 32

• Patient has been offered CPAP and has refused or failed to continue CPAP treatment

• Identified evidence of airway collapse, primarily at the base of the tongue

• Signed informed consent to participate in this clinical study

Exclusion Criteria:

• Prior OSA surgery except tonsillectomy, nasal surgery and uvulopalatopharyngoplasty; no airway surgery within 3 months prior to enrollment.

• Airway collapse at the level of the soft palate (palatal collapse).

• Enlarged tonsils (3+ and 4+)

• Anatomy unable to accommodate the implant

• Severe mandibular deficiency/retrognathia

• Unable and/or not willing to comply with treatment follow-up requirements.

• Pregnancy. (Female subjects of childbearing potential must have a negative pregnancy test prior to enrollment and should maintain adequate contraception during the study)

• Breastfeeding women

• Active systemic infection

• Allergy to any medication used during implantation

• Previous history of neck or upper respiratory tract cancer

• History of radiation therapy to neck or upper respiratory tract

• Dysphagia

• Major cardiovascular and pulmonary disorders

• Other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment and the procedures and evaluations pre- and post-treatment

• Enrollment in another pharmacological or medical device study that may effect or bias the results of this clinical study

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Aspire Medical Advance System
The treatment includes a device that is surgically implanted in the tongue and lower jaw. The purpose of the implant is to prevent obstruction of the upper airway thereby improving breathing during sleep.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen	Egedem
Czech Republic	LENTE	Plzen
Germany	University Hospital Mannheim	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Aspire Medical

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstrate the feasibility of tongue stabilization using the Advance™ System. Product implantation and stabilization of the tongue using the Advance™system will be measured by Pharyngoscopy and Cephalogram		3 months	No
Primary	Evaluate the safety of the Advance™ System 3 Months after implantation.		3 months	Yes
Primary	Compare baseline and 6 month apnea-hypopnea indices as measured by PSG studies.		6 months	No
Secondary	Epworth Sleepiness Scale (ESS) measured at 3 Months post-implantation		3 months	No
Secondary	Functional Outcomes of Sleep Questionnaire (FOSQ) measured at 3 Months post-implantation		3 months	No