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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03506178
• Other study ID #: TRECKY2017-1109
• Status: Recruiting
• Phase: N/A
• First received: April 12, 2018
• Last updated: April 21, 2018
• Start date: September 12, 2017
• Est. completion date: May 12, 2018

Study information

• Verified date: April 2018
• Source: Beijing Tongren Hospital
• Contact: Yunsong An, MD
• Phone: 8618801119312
• Email: anyunsong[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 12, 2018
• Est. primary completion date: May 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Oxymetazoline Nasal Spray
Obstructive sleep apnea (OSA) Patients and healthy controls 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, polysomnograpy, genioglossus enlectromyography, pharyngeal current perception threshold and sleep quality scores were assess.
• Menthol Nasal Spray
Obstructive sleep apnea (OSA) Patients and healthy controls 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, polysomnograpy, genioglossus enlectromyography, pharyngeal current perception threshold and sleep quality scores were assess.
• Normal saline Nasal Spray
Obstructive sleep apnea (OSA) Patients and healthy controls 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, polysomnograpy, genioglossus enlectromyography, pharyngeal current perception threshold and sleep quality scores were assess.

Device:
• Nasal mask with partly blocked
Obstructive sleep apnea (OSA) Patients and healthy controls 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, polysomnograpy, genioglossus enlectromyography, pharyngeal current perception threshold and sleep quality scores were assess.

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-hypopnea Index	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.	2 to 6 month
Primary	Myoelectricity of genioglossus	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.	2 to 6 month
Primary	The pharyngeal current sensory threshold	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.	2 to 6 month