Obstructive Sleep Apnea
Conditions
Keywords
Upper airway, Obstructive sleep apnea, Polysomnography
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
Interventions
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.
DRUGMenthol 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.
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.
DEVICENasal 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.
Sponsors
Beijing Tongren Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactYunsong An, MD
Outcome results
None listed