The Effects of Nasal Airflow on Upper Airway Dilator Muscles During Sleep

Capital Medical University

Status: Unknown

Conditions: Obstructive Sleep Apnea

Treatments: Drug: Oxymetazoline Nasal Spray; Drug: Menthol Nasal Spray; Drug: Normal saline Nasal Spray; Device: Nasal mask with partly blocked

Study type: Interventional

Funder types: Other

Identifiers

NCT03506178

TRECKY2017-1109

Details and patient eligibility

About

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.

Full description

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 Pharyngeal electrical current sensory threshold was performed to identify the different Pharyngeal function between OSA patients and normal controls

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Obstructive sleep apnea patients

Experimental group

Treatment:

Device: Nasal mask with partly blocked

Drug: Normal saline Nasal Spray

Drug: Menthol Nasal Spray

Drug: Oxymetazoline Nasal Spray

Healthy controls

Other group

Treatment:

Device: Nasal mask with partly blocked

Drug: Normal saline Nasal Spray

Drug: Menthol Nasal Spray

Drug: Oxymetazoline Nasal Spray