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

Capital Medical University logo

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

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

Trial contacts and locations

1

Loading...

Central trial contact

Yunsong An, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems