Clinical trial NCT04192656: The Effect of PAP on ISSHL Comorbided With OSA
Official title: The Effect of Positive Airway Pressure on Idiopathic Sudden Sensorineural Hearing Loss Comorbided With Obstructive Sleep Apnea: A Clinical Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Sudden Hearing Loss
Obstructive Sleep Apnea
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: hearing threshold
timeFrame: 3 months after onset of ISSHL
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinhgua Changgung Hospital
state: Beijing
Study officials:
affiliation: Beijing Tsinghua Changung Hospital
name: Juanjuan Gao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tsinghua Changung Hospital
name: jingying Ye, MD
role: STUDY_CHAIR
affiliation: Beijing Tsinghua Changung Hospital
name: Haijin Yi, MD
role: STUDY_DIRECTOR
affiliation: Beijing Tsinghua Changung Hospital
name: Mu He, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tsinghua Changung Hospital
name: Xin Cao, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tsinghua Changung Hospital
name: Xingxing Lu, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tsinghua Changung Hospital
name: Sichao Liang, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.
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.
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.