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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAP plus medication | Experimental | patients treated by both PAP and medication |
|
| medication | Active Comparator | patients treated by medication only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-invasive positive airway pressure | Device | non-invasive positive airway pressure is the first-line treatment for obstructive sleep apnea |
|
| Measure | Description | Time Frame |
|---|---|---|
| hearing threshold | the recovery of hearing threshold which will be measured by pure tone audiometry | 3 months after onset of ISSHL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingying Ye, MD | Contact | +86-13701396970 | yejingying@163.vip.com | |
| Haijin Yi, MD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Juanjuan Gao, MD | Beijing Tsinghua Changung Hospital | Principal Investigator |
| jingying Ye, MD | Beijing Tsinghua Changung Hospital | Study Chair |
| Haijin Yi, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tsinhgua Changgung Hospital | Recruiting | Beijing | Beijing Municipality | 100028 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23710145 | Background | 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. | |
| 25388224 | 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. |
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| ID | Term |
|---|---|
| D003639 | Hearing Loss, Sudden |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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Not provided
| ID | Term |
|---|---|
| D008776 | Methylprednisolone Hemisuccinate |
| D008775 | Methylprednisolone |
| C526713 | ginaton |
| C063170 | Ginkgo biloba extract |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| Methylprednisolone Hemisuccinate | Drug | Methylprednisolone is the first-line treatment of idiopathic sudden sensorineural hearing loss |
|
|
| Ginaton | Drug | ginnaton is ginkgo biloba extract |
|
|
| 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 |
| 21479758 | 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. |
| 30134647 | 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. |
| 22249630 | 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. |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |