The Effect of PAP on ISSHL Comorbided With OSA

NCT04192656 | Recruiting Phase 4 DMC

• 1 other identifier: BTCHENT201901
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sudden Hearing Loss; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• hearing threshold

  the recovery of hearing threshold which will be measured by pure tone audiometry

  3 months after onset of ISSHL

Study Arms (2)

PAP plus medication

EXPERIMENTAL

patients treated by both PAP and medication

Device: non-invasive positive airway pressure; Drug: Methylprednisolone Hemisuccinate; Drug: Ginaton

medication

ACTIVE COMPARATOR

patients treated by medication only

Drug: Methylprednisolone Hemisuccinate; Drug: Ginaton

Interventions

non-invasive positive airway pressure DEVICE

non-invasive positive airway pressure is the first-line treatment for obstructive sleep apnea

PAP plus medication

Methylprednisolone Hemisuccinate DRUG

Methylprednisolone is the first-line treatment of idiopathic sudden sensorineural hearing loss

Also known as: Methylprednisolone, MP

PAP plus medication; medication

Ginaton DRUG

ginnaton is ginkgo biloba extract

Also known as: Ginkgo biloba extract,GBE

PAP plus medication; medication

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinhgua Changgung Hospital

Beijing, Beijing Municipality, 100028, China

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Sudden; Sleep Apnea, Obstructive

Interventions

Methylprednisolone Hemisuccinate; Methylprednisolone; ginaton; Ginkgo biloba extract

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Juanjuan Gao, MD

  Beijing Tsinghua Changung Hospital

  PRINCIPAL INVESTIGATOR

• jingying Ye, MD

  Beijing Tsinghua Changung Hospital

  STUDY CHAIR

• Haijin Yi, MD

  Beijing Tsinghua Changung Hospital

  STUDY DIRECTOR

• Mu He, MD

  Beijing Tsinghua Changung Hospital

  PRINCIPAL INVESTIGATOR

• Xin Cao, MA

  Beijing Tsinghua Changung Hospital

  PRINCIPAL INVESTIGATOR

• Xingxing Lu, MA

  Beijing Tsinghua Changung Hospital

  PRINCIPAL INVESTIGATOR

• Sichao Liang, MA

  Beijing Tsinghua Changung Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingying Ye, MD

CONTACT

+86-13701396970; yejingying@163.vip.com

Haijin Yi, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the dept. of Otolaryngology, Head and Neck Surgery, and Director of the Center of Sleep Medicine

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 10, 2019
• Study Start: November 1, 2019
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 10, 2019

Record last verified: 2019-12

Locations

CN (1)