Clinical trial NCT03506178: The Effects of Nasal Airflow on Upper Airway Dilator Muscles During Sleep
Official title: The Effects of Nasal Airflow on Upper Airway Dilator Muscles During Sleep
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Upper airway
Obstructive sleep apnea
Polysomnography
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2018-04-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Obstructive sleep apnea (OSA) is an increasingly prevalent disorder characterized by repeated upper airway collapse during sleep, resulting in oxygen desaturation and frequent arousals. The etiology of OSA remains unclear.

Many studies indicates an association between nasal obstruction and apnea. However,the precise nature of this relationship is far from clear and the importance of resistance to nasal airflow in the pathogenesis of airway collapse in OSA patients remains contentious.

In this study, investigators perform 4 different ways to change subjective or objective patency of nasal cavity and observe the effects of the nasal airflow on nocturnal breathing, sleep,and upper airway muscles in OSA patients.

Detailed description: 1. All subjects underwent a standard overnight polysomnogram(PSG), including continuous genioglossal electromyography measurement , electroencephalogram, electrooculogram, electrocardiogram, nasal flow (thermister), respiratory (chest and abdominal) movements,oxy-hemoglobin saturation (pulse oximeter), and body position. Apnea event definitions and clinical classification were determined using the American Academy of Sleep Medicine(AASM) guidelines
2. Pharyngeal electrical current sensory threshold was performed to identify the different Pharyngeal function between OSA patients and normal controls

Eligibility criteria: Inclusion Criteria:

* OSA patients (apnea/hyponea index \>5/h）with chronic nasal congestion

Exclusion Criteria:

* Upper airway surgery;
* Current treatment with nasal topical steroids or decongestants;
* Internal medical diseases or psychiatric disorders that interferd with sleep.

Primary outcomes:
measure: Apnea-hypopnea Index
timeFrame: 2 to 6 month
measure: Myoelectricity of genioglossus
timeFrame: 2 to 6 month
measure: The pharyngeal current sensory threshold
timeFrame: 2 to 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
Study officials:
affiliation: Beijing Tongren Hospital
name: Demin Han, MD,PhD
role: STUDY_DIRECTOR
References:
citation: An Y, Gao F, Su X, Zhou C, Huang J, Chen S, Liu T, Lu Z. Characteristics of pharyngeal paraesthesia symptoms in patients with obstructive sleep apnoea. Sleep Breath. 2021 Dec;25(4):2163-2169. doi: 10.1007/s11325-021-02325-z. Epub 2021 Feb 18.
citation: An Y, Li Y, Chang W, Gao F, Ding X, Xu W, Han D. Quantitative Evaluation of the Function of the Sensory Nerve Fibers of the Palate in Patients With Obstructive Sleep Apnea. J Clin Sleep Med. 2019 Sep 15;15(9):1347-1353. doi: 10.5664/jcsm.7756.
citation: An Y, Li L, Li Y, Chang W, Chen S, Gao F, Ding X, Xu W, Han D. Quantitative Evaluation of the Function of the Sensory Nerve Fibers of the Palate in Patients With Obstructive Sleep Apnea. J Clin Sleep Med. 2019 Apr 30:jc-18-00522. Online ahead of print.
citation: An Y, Li Y, Kang D, Sharama-Adhikari SK, Xu W, Li Y, Han D. The effects of nasal decongestion on obstructive sleep apnoea. Am J Otolaryngol. 2019 Jan-Feb;40(1):52-56. doi: 10.1016/j.amjoto.2018.08.003. Epub 2018 Aug 23.