Multi-center safety and efficacy study of a negative-pressure intraoral device in obstructive sleep apnea.

Autor: Nilius G; Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH, Essen-Mitte, Germany; University Witten-Herdecke, Witten, Germany. Electronic address: G.Nilius@kem-med.com., Farid-Moayer M; Peninsula Sleep Centre, Burlingame, CA, USA., Lin CM; Shin Kong Wu Ho-Su Memorial Hospital, Taipei City, Taiwan., Knaack L; INTERSOM Köln, Cologne, Germany., Wang YP; Mackay Memorial Hospital, Taipei Branch, Taipei City, Taiwan., Dellweg D; Fachkrankenhaus Kloster Grafschaft GmbH, Schmallenberg, Germany., Stoohs R; Somnolab Schlaflabor, Essen/Dortmund, Germany., Ficker J; 3rd Medical Department (Respiratory Medicine) Klinikum Nuernberg, Paracelsus Medical University, Nuernberg, Germany., Randerath W; Krankenhaus Bethanien, Solingen, Germany., Specht MB; Zentrum für interdisziplinnäre Schlafmedizin, DKD Wiesbaden, Wiesbaden, Germany., Galetke W; HELIOS Klinik Hagen, Hagen, Germany., Schneider H; American Sleep Clinic, Frankfurt, Germany.
Jazyk: angličtina
Zdroj: Sleep medicine [Sleep Med] 2024 Jul; Vol. 119, pp. 139-146. Date of Electronic Publication: 2024 Apr 17.
DOI: 10.1016/j.sleep.2024.04.015
Abstrakt: Background: Intraoral devices, with or without negative oral pressure, can stabilize the oropharynx and reduce obstructive sleep apneas. We tested the hypothesis that treatment with the iNAP® Sleep Therapy System, which applies negative oral pressure through an intra-oral appliance, would reduce the severity of obstructive sleep apnea in a multi-center, prospective, first-night-randomized-order cross-over study.
Methods/patients: 130 patients fulfilled the entry criteria (age <75, AHI 15-55, BMI <33), and 63 entered the primary endpoint cohort (Total Sleep Time ≥4 h/night on the baseline polysomnogram and an oral negative vacuum time maintained by iNAP® ≥ 4 h/night and total sleep time ≥4 h/night during the first treatment study). 54 patients completed a second treatment sleep study at least 28 days after the first sleep study.
Results: Among the primary endpoint cohort (n = 63, age = 53.2 ± 11.3, BMI = 27.1 ± 2.8), 33 patients (52 %; 95 % confidence interval = 40%-64 %, p < 0.001) responded to iNAP treatment according to the Sher criteria (>50 % reduction in AHI and an AHI ≤20 events/hr). The average oxy-hemoglobin saturation increased by 1-2%, and the average percent oxygen desaturation decreased (was less severe) by 1 % while using the iNAP device. The incidence of adverse events, all self-limited, was low. The reduction in the apnea-hypopnea index was durable over the 28-day study. Patients used iNAP on average 5.6 h per night during the study period.
Conclusion: The iNAP® Sleep Therapy System achieved a durable benefit in more than half the patients with moderate to severe obstructive sleep apnea and may be considered in patients who object to or failed continuous positive airway pressure.
Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT02698059.
Competing Interests: Declaration of Competing interest The corresponding author, on behalf of all the authors of this submission, disclose the following financial and/or personal relationships with other people or organizations that could inappropriately influence (bias) this work.
(Copyright © 2024 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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