Upper Airway Stimulation Versus Continuous Positive Airway Pressure

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: continuous positive airway pressure; Device: upper airway stimulation

• Registration Number: NCT03756805
• Lead Sponsor: Technical University of Munich

Brief Summary

Standard therapy in patients with obstructive sleep apnea (OSA) is continuous positive airway pressure (CPAP). 30% to 50% are not adherent to this therapy and need an alternative treatment. Hypoglossal nerve stimulation or selective upper airway stimulation has been developed since several years. The aim of this clinical trial is to compare both treatments with each other.

Detailed Description

6% to 13% of the western industrialized population suffer from obstructive sleep apnea (OSA). During sleep in the pharyngeal airway a relaxation of the muscles occurs with increasing depth of sleep. Finally, this relaxation, due to the anatomical conditions, lead to obstructions of the respiratory tract, resulting in respiratory arrest (apnea) and minor respiratory changes such as hypopneas or flow limitations. The symptoms of this disease manifest themselves with varying degrees. Increased daytime sleepiness, snoring, and increased risk of cardiovascular disease can result. A significant reduction in overall quality of life can be associated with OSAS. The gold standard treatment for obstructive sleep apnea is CPAP (continuous positive airway pressure). But only about 50% to 70% of patients continue to use their device after 2 years of initial CPAP therapy. This means that 30% to 50% of patients are no longer cared for their obstructive sleep apnea. A certain proportion of younger patients, in particular, reject nocturnal ventilation therapy with CPAP from the beginning. For these patients selective upper airway stimulation (UAS) is a therapy option.

Therefore the patient receives surgically a subcutaneous stimulation device under the clavicle, which receives a signal from a respiratory sensor to selectively stimulate the hypoglossal nerve. The respiratory sensor is located in the 4th or 5th intercostal space between the patient's external and internal rib muscles. This can be used to record the patient's breathing, which allows a matched stimulation of the hypoglossal nerve. The actual stimulation lead is attached to the medial branches of the hypoglossal nerve, which are responsible for the protrusion of the tongue, in order to enable appropriate stimulation.

In this prospective cohort study, selective upper airway stimulation (UAS) will now be compared with CPAP therapy. Patients receiving CPAP therapy are compared to UAS patients who receive an upper airway stimulation. Both methods are procedures established in clinical routine, and during this investigation, the general clinical course is not deviated. Randomization does not occur because CPAP therapy is a conservative therapy and UAS therapy is a surgical therapy. Furthermore, for UAS therapy, there must be a CPAP incompliance, so that a surgical concept is justified. The CPAP group should comply with the body mass index and age of the UAS group.

Study Timeline

• Study Start: 2018-07-06
• Study First Submitted: 2018-11-27
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-28
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

Inclusion Criteria

• All consecutive patients who either received UAS implantation (Inspire therapy) in our Department of Otorhinolaryngology, Head and Neck Surgery at the Klinikum rechts der Isar and all patients who received a CPAP therapy since July 2013, are invited to participate in this clinical examination.

Exclusion Criteria

• patients with the age under 18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (CPAP)	continuous positive airway pressure	Patient, who are receiving a CPAP
Group 2 (UAS)	upper airway stimulation	Patient, who are receiving a device for upper airway stimulation

Primary Outcome Measures

Name	Time	Method
AHI	reduction from baseline to 12 months	Apnea Hypopnea Index measured in events per hour
ODI	reduction from baseline to 12 months	Oxygen desaturation index measured in events per hour

Secondary Outcome Measures

Name	Time	Method
ESS	improvement from baseline to 12 months	Epworth Sleepiness Scale
FOSQ	improvement from baseline to 12 months	Functional Outcome of Sleep Questionnaire
Usage	usage hours per night at 12 months	Usage Hour per Night

Trial Locations

Locations (1)

Technical University of Munich; 🇩🇪 Munich, Bavaria, Germany