The Effect of PAP on ISSHL Comorbided With OSA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: non-invasive positive airway pressure, Methylprednisolone Hemisuccinate, Ginaton.
- Who it may be relevant to
- Registry conditions: Sudden Hearing Loss, Obstructive Sleep Apnea. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Positive Airway Pressure on Idiopathic Sudden Sensorineural Hearing Loss Comorbided With Obstructive Sleep Apnea: A Clinical Randomized Controlled Study
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.
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
Primary outcome measures
- hearing threshold [Time frame: 3 months after onset of ISSHL]
Eligibility criteria
Inclusion criteria
- aged >= 18 and <= 70,
- diagnosed with OSA by full-night in-lab or home-stay PSG according to AASM 2012 criteria, and AHI > 15/h,
- diagnosed with ISSHL by AAO-HNS 2019 criteria,
- ISSHL onset within 1 week.
Exclusion criteria
- sudden hearing loss with certain causes,
- with severe comorbid diseases,
- pregnant or breast-feeding women,
- AHI <= 15/h,
- hearing threshold recovered > 50% when included,
- previously regularly treated with PAP.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Tsinhgua Changgung Hospital — Beijing
Publications
- 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. PMID 23710145
- 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. PMID 25388224
- 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. PMID 21479758
- 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. PMID 30134647
- 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. PMID 22249630
Identifiers
NCT: NCT04192656 · BTCHENT201901