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

NCT03506178 | Unknown

• 1 other identifier: TRECKY2017-1109
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

Upper airway; Obstructive sleep apnea; Polysomnography

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Obstructive sleep apnea patients

EXPERIMENTAL

Drug: Oxymetazoline Nasal Spray; Drug: Menthol Nasal Spray; Drug: Normal saline Nasal Spray; Device: Nasal mask with partly blocked

Healthy controls

OTHER

Drug: Oxymetazoline Nasal Spray; Drug: Menthol Nasal Spray; Drug: Normal saline Nasal Spray; Device: Nasal mask with partly blocked

Interventions

Oxymetazoline Nasal Spray DRUG

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.

Healthy controls; Obstructive sleep apnea patients

Menthol Nasal Spray DRUG

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.

Healthy controls; Obstructive sleep apnea patients

Normal saline Nasal Spray DRUG

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.

Healthy controls; Obstructive sleep apnea patients

Nasal mask with partly blocked DEVICE

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.

Healthy controls; Obstructive sleep apnea patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• OSA patients (apnea/hyponea index \>5/h）with chronic nasal congestion

You may not qualify if:

• Upper airway surgery;
• Current treatment with nasal topical steroids or decongestants;
• Internal medical diseases or psychiatric disorders that interferd with sleep.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 33604802 DERIVED

• 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.

  PMID: 31538606 DERIVED

• 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.

  PMID: 30243839 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Demin Han, MD,PhD

  Beijing Tongren Hospital

  STUDY DIRECTOR

Central Study Contacts

Yunsong An, MD

CONTACT

8618801119312; anyunsong@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: April 24, 2018
• Study Start: September 12, 2017
• Primary Completion: May 12, 2018
• Study Completion: May 12, 2018
• Last Updated: April 24, 2018

Record last verified: 2018-04

Locations

CN (1)