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

Not Applicable

• Conditions: Obstructive Sleep Apnea
• Interventions: Drug: Oxymetazoline Nasal Spray; Drug: Menthol Nasal Spray; Drug: Normal saline Nasal Spray; Device: Nasal mask with partly blocked

• Registration Number: NCT03506178
• Lead Sponsor: Beijing Tongren Hospital

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

Study Timeline

• Study Start: 2017-09-12
• Status Verified: 2018-04
• Study First Submitted: 2018-04-12
• Study First Submitted QC: 2018-04-21
• Last Update Submitted: 2018-04-21
• Study First Posted: 2018-04-24
• Last Update Posted: 2018-04-24
• Primary Completion: 2018-05-12
• Study Completion: 2018-05-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Obstructive sleep apnea patients	Oxymetazoline Nasal Spray	-
Healthy controls	Oxymetazoline Nasal Spray	-
Obstructive sleep apnea patients	Menthol Nasal Spray	-
Healthy controls	Menthol Nasal Spray	-
Obstructive sleep apnea patients	Normal saline Nasal Spray	-
Obstructive sleep apnea patients	Nasal mask with partly blocked	-
Healthy controls	Normal saline Nasal Spray	-
Healthy controls	Nasal mask with partly blocked	-

Primary Outcome Measures

Name	Time	Method
Myoelectricity of genioglossus	2 to 6 month	Participants were treated with 4 different nasal intervention ,including Oxymetazoline Nasal Spray, Normal saline Nasal Spray, Menthol Nasal Spray or Nasal mask with partly blocked when they sleep onset. At the treatment periods, subjects underwent overnight polysomnography with synchronous genioglossus electromyography . Genioglossus (GG) activations under different nasal ventilation conditions were compared.
Apnea-hypopnea Index	2 to 6 month	A randomized, placebo-controlled double blind study on the effects of nasal spray oxymetazoline on sleep architecture, respiratory events, body position and subjective scores in OSA patients. All participants received specific physical examinations, subjective scale assessments and a two-night polysomnography sduty (by randomly applying oxymetazoline for one night and placebo for another.).Data collected after oxymetazoline or placebo treatments were compared. Apnea-hypopnea index(AHI),defined as the sum of apneas and hypopneas per sleep hour, was used as an important indicator for assess the severity of OSA.
The pharyngeal current sensory threshold	2 to 6 month	The pharyngeal current perception threshold test was performed before and after different nasal intervention including Oxymetazoline Nasal Spray, Normal saline Nasal Spray, Menthol Nasal Spray or Nasal mask with partly blocked different nasal cavities. Data collected from OSA patients and healthy controls were compared and analyzed.

Trial Locations

Locations (1)

Beijing Tongren Hospital; 🇨🇳 Beijing, Beijing, China