Upper Airway Stimulation Versus Continuous Positive Airway Pressure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

227 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-06

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Upper Airway Stimulation in Patients With Obstructive Sleep Apnea

NCT03760328

Obstructive Sleep Apnea

COMPLETED NA

Obstructive Sleep Apnea Therapy by Stimulation of the Hypoglossal Nerve

NCT03844295

Obstructive Sleep Apnea Syndrome

COMPLETED NA

Stimulation Therapy for Apnea: Reporting Thoughts

NCT04768543

Obstructive Sleep Apnea

COMPLETED

Assessment of the Effect of Hypoglossal Nerve Stimulation Therapy on Upper Airway Collapsibility During Drug-induced Sleep Endoscopy

NCT07337239

Obstructive Sleep Apnea

NOT_YET_RECRUITING NA

Phonoaudiologic Therapy Adjunct to Treatment on Patients With Obstructive Sleep Apnea

NCT01289405

Obstructive Sleep Apnea Syndrome

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obstructive Sleep Apnea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Patients with moderate to severe sleep apnea (apnea-hypopnea index (AHI) between 15 / h and 65 / h) are included in the period 2014-2018. The patients are assigned to two groups: group 1, who are receiving PAP therapy and group 2, who are receiving upper airway stimulation. All patients receive polysomnography (PSG) in the sleep laboratory prior to therapy and are followed up on average 12 months after initiation of therapy by PSG or a home sleep test. This protocol is close to the daily clinical routine.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1 (CPAP)

Patient, who are receiving a CPAP

Group Type ACTIVE_COMPARATOR

continuous positive airway pressure

Intervention Type DEVICE

One group of patients with CPAP

Group 2 (UAS)

Patient, who are receiving a device for upper airway stimulation

Group Type EXPERIMENTAL

upper airway stimulation

Intervention Type DEVICE

One group of patients with UAS

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.