- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03506178
The Effects of Nasal Airflow on Upper Airway Dilator Muscles During Sleep
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.
Study Overview
Status
Conditions
Detailed 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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yunsong An, MD
- Phone Number: 8618801119312
- Email: anyunsong@126.com
Study Locations
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Beijing
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Beijing, Beijing, China, 100730
- Recruiting
- Beijing Tongren Hospital
-
Contact:
- Yunsong An, M.D
- Phone Number: 86-18801119312
- Email: anyunsong@126.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Healthy controls
|
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.
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.
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.
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.
|
Experimental: Obstructive sleep apnea patients
|
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.
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Apnea-hypopnea Index
Time Frame: 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.
|
2 to 6 month
|
Myoelectricity of genioglossus
Time Frame: 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.
|
2 to 6 month
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The pharyngeal current sensory threshold
Time Frame: 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.
|
2 to 6 month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Demin Han, MD,PhD, Beijing Tongren Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Respiratory Tract Diseases
- Apnea
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Dermatologic Agents
- Respiratory System Agents
- Antipruritics
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Phenylephrine
- Oxymetazoline
- Menthol
Other Study ID Numbers
- TRECKY2017-1109
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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