- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03756805
Upper Airway Stimulation Versus Continuous Positive Airway Pressure
Selective Upper Airway Stimulation Compared to Continuous Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea: a Prospective Cohort Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Bavaria
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Munich, Bavaria, Tyskland, 81667
- Technical University of Munich
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Group 1 (CPAP)
Patient, who are receiving a CPAP
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One group of patients with CPAP
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Eksperimentel: Group 2 (UAS)
Patient, who are receiving a device for upper airway stimulation
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One group of patients with UAS
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
AHI
Tidsramme: reduction from baseline to 12 months
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Apnea Hypopnea Index measured in events per hour
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reduction from baseline to 12 months
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ODI
Tidsramme: reduction from baseline to 12 months
|
Oxygen desaturation index measured in events per hour
|
reduction from baseline to 12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
ESS
Tidsramme: improvement from baseline to 12 months
|
Epworth Sleepiness Scale
|
improvement from baseline to 12 months
|
FOSQ
Tidsramme: improvement from baseline to 12 months
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Functional Outcome of Sleep Questionnaire
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improvement from baseline to 12 months
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Usage
Tidsramme: usage hours per night at 12 months
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Usage Hour per Night
|
usage hours per night at 12 months
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UAS vs. CPAP
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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