The Effect of PAP on ISSHL Comorbided With OSA

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04192656
• Other study ID #: BTCHENT201901
• Status: Recruiting
• Phase: Phase 4
• Start date: November 1, 2019
• Est. completion date: December 2029

Study information

• Verified date: December 2019
• Source: Beijing Tsinghua Chang Gung Hospital
• Contact: Jingying Ye, MD
• Phone: +86-13701396970
• Email: yejingying[@]163.vip.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: December 2029
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sudden
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sudden Hearing Loss

Intervention

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
• Ginaton
ginnaton is ginkgo biloba extract

Locations

Country	Name	City	State
China	Beijing Tsinhgua Changgung Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tsinghua Chang Gung Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

Hizli Ö, Özcan M, Ünal A. Evaluation of comorbidities in patients with OSAS and simple snoring. ScientificWorldJournal. 2013 Apr 18;2013:709292. doi: 10.1155/2013/709292. Print 2013. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hearing threshold	the recovery of hearing threshold which will be measured by pure tone audiometry	3 months after onset of ISSHL