The Effect of PAP on ISSHL Comorbided With OSA

Overview

This clinical randomized controlled study is to explore the effect of positive airway pressure(PAP) on patients in Beijing Tsinghua Changgung Hospital diagnosed with both idiopathic sudden sensorineural hearing loss comorbided(ISSHL) and obstructive sleep apnea(OSA) between Dec. 2019 to Dec. 2029.

Full Title of Study: “The Effect of Positive Airway Pressure on Idiopathic Sudden Sensorineural Hearing Loss Comorbided With Obstructive Sleep Apnea: A Clinical Randomized Controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2024

Interventions

  • Device: non-invasive positive airway pressure
    • non-invasive positive airway pressure is the first-line treatment for obstructive sleep apnea
  • Drug: Methylprednisolone Hemisuccinate
    • Methylprednisolone is the first-line treatment of idiopathic sudden sensorineural hearing loss
  • Drug: Ginaton
    • ginnaton is ginkgo biloba extract

Arms, Groups and Cohorts

  • Experimental: PAP plus medication
    • patients treated by both PAP and medication
  • Active Comparator: medication
    • patients treated by medication only

Clinical Trial Outcome Measures

Primary Measures

  • hearing threshold
    • Time Frame: 3 months after onset of ISSHL
    • the recovery of hearing threshold which will be measured by pure tone audiometry

Participating in This Clinical Trial

Inclusion Criteria

1. aged >= 18 and <= 70, 2. diagnosed with OSA by full-night in-lab or home-stay PSG according to AASM 2012 criteria, and AHI > 15/h, 3. diagnosed with ISSHL by AAO-HNS 2019 criteria, 4. ISSHL onset within 1 week. Exclusion Criteria:

1. sudden hearing loss with certain causes, 2. with severe comorbid diseases, 3. pregnant or breast-feeding women, 4. AHI <= 15/h, 5. hearing threshold recovered > 50% when included, 6. previously regularly treated with PAP.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Beijing Tsinghua Chang Gung Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ye Jingying, Director of the dept. of Otolaryngology, Head and Neck Surgery, and Director of the Center of Sleep Medicine – Beijing Tsinghua Chang Gung Hospital
  • Overall Official(s)
    • Juanjuan Gao, MD, Principal Investigator, Beijing Tsinghua Changung Hospital
    • jingying Ye, MD, Study Chair, Beijing Tsinghua Changung Hospital
    • Haijin Yi, MD, Study Director, Beijing Tsinghua Changung Hospital
    • Mu He, MD, Principal Investigator, Beijing Tsinghua Changung Hospital
    • Xin Cao, MA, Principal Investigator, Beijing Tsinghua Changung Hospital
    • Xingxing Lu, MA, Principal Investigator, Beijing Tsinghua Changung Hospital
    • Sichao Liang, MA, Principal Investigator, Beijing Tsinghua Changung Hospital
  • Overall Contact(s)
    • Jingying Ye, MD, +86-13701396970, yejingying@163.vip.com

References

Hizli O, Ozcan M, Unal A. Evaluation of comorbidities in patients with OSAS and simple snoring. ScientificWorldJournal. 2013 Apr 18;2013:709292. doi: 10.1155/2013/709292. Print 2013.

Kayabasi S, Iriz A, Cayonu M, Cengiz B, Acar A, Boynuegri S, Mujdeci B, Eryilmaz A. Vestibular functions were found to be impaired in patients with moderate-to-severe obstructive sleep apnea. Laryngoscope. 2015 May;125(5):1244-8. doi: 10.1002/lary.25021. Epub 2014 Nov 12.

Casale M, Vesperini E, Potena M, Pappacena M, Bressi F, Baptista PJ, Salvinelli F. Is obstructive sleep apnea syndrome a risk factor for auditory pathway? Sleep Breath. 2012 Jun;16(2):413-7. doi: 10.1007/s11325-011-0517-x. Epub 2011 Apr 9.

Fu Q, Wang T, Liang Y, Lin Y, Zhao X, Wan J, Fan S. Auditory Deficits in Patients With Mild and Moderate Obstructive Sleep Apnea Syndrome: A Speech Syllable Evoked Auditory Brainstem Response Study. Clin Exp Otorhinolaryngol. 2019 Feb;12(1):58-65. doi: 10.21053/ceo.2018.00017. Epub 2018 Aug 24.

Sheu JJ, Wu CS, Lin HC. Association between obstructive sleep apnea and sudden sensorineural hearing loss: a population-based case-control study. Arch Otolaryngol Head Neck Surg. 2012 Jan;138(1):55-9. doi: 10.1001/archoto.2011.227.

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