Clinical trial NCT03756805: Upper Airway Stimulation Versus Continuous Positive Airway Pressure
Official title: Selective Upper Airway Stimulation Compared to Continuous Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea: a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
hypoglossal nerve stimulation
upper airway stimulation
surgical treatment sleep apnea
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: AHI
timeFrame: reduction from baseline to 12 months
measure: ODI
timeFrame: reduction from baseline to 12 months
Secondary outcomes:
measure: ESS
timeFrame: improvement from baseline to 12 months
measure: FOSQ
timeFrame: improvement from baseline to 12 months
measure: Usage
timeFrame: usage hours per night at 12 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Technical University of Munich
state: Bavaria
Study officials:
References:
citation: Heiser C, Steffen A, Strollo PJ Jr, Giaie-Miniet C, Vanderveken OM, Hofauer B. Hypoglossal nerve stimulation versus positive airway pressure therapy for obstructive sleep apnea. Sleep Breath. 2023 May;27(2):693-701. doi: 10.1007/s11325-022-02663-6. Epub 2022 Jul 2.