Obstructive Sleep ApneaNCT03506178
The Effects of Nasal Airflow on Upper Airway Dilator Muscles During Sleep
A study testing Oxymetazoline Nasal Spray, Menthol Nasal Spray and Normal saline Nasal Spray in people with Obstructive Sleep Apnea, run by Beijing Tongren Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Oxymetazoline Nasal Spray, Menthol Nasal Spray and Normal saline Nasal Spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 12 Sep 2017to 12 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- OSA patients (apnea/hyponea index >5/h）with chronic nasal congestion
Who cannot join
- Upper airway surgery;
- Current treatment with nasal topical steroids or decongestants;
- Internal medical diseases or psychiatric disorders that interferd with sleep.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tongren Hospital
Beijing, Beijing Municipality, 100730
Yunsong An, M.D, 86-18801119312, anyunsong@126.com
About this study
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.
Read the 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
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Oxymetazoline Nasal Spray, Menthol Nasal Spray, Normal saline Nasal Spray, Nasal mask with partly blocked
- Keywords
- Upper airway, Obstructive sleep apnea, Polysomnography
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxymetazoline Nasal SprayDrug
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 SprayDrug
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 SprayDrug
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.
Nasal mask with partly blockedDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Obstructive sleep apnea patients | Experimental | Not described Receives: Drug: Oxymetazoline Nasal Spray; Drug: Menthol Nasal Spray; Drug: Normal saline Nasal Spray; Device: Nasal mask with partly blocked |
| Healthy controls | Other | Not described Receives: Drug: Oxymetazoline Nasal Spray; Drug: Menthol Nasal Spray; Drug: Normal saline Nasal Spray; Device: Nasal mask with partly blocked |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2 to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start12 Sep 2017
- Primary completion12 May 2018 (estimated)
- Study completion12 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Demin Han, MD,PhD, Study director, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506178
- Sponsor's protocol ID
- TRECKY2017-1109
- Status last verified
- Apr 2018
- First submitted
- 12 Apr 2018
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 33604802An 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.
PubMed 31538606An 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.
PubMed 30243839
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Nasal Airflow on Upper Airway Dilator Muscles During Sleep
- ClinicalTrials.gov ID
- NCT03506178
- Acronym / sponsor ID
- TRECKY2017-1109
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Upper airway, Obstructive sleep apnea, Polysomnography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 12 May 2018 (estimated)
- Study completion
- 12 May 2018 (estimated)
- First posted
- 24 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- OSA patients (apnea/hyponea index >5/h）with chronic nasal congestion
Key exclusion criteria (3 listed)
- Upper airway surgery;
- Current treatment with nasal topical steroids or decongestants;
- Internal medical diseases or psychiatric disorders that interferd with sleep.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxymetazoline Nasal SprayObstructive 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. | Drug | Healthy controls, Obstructive sleep apnea patients |
| Menthol Nasal SprayObstructive 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. | Drug | Healthy controls, Obstructive sleep apnea patients |
| Normal saline Nasal SprayObstructive 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. | Drug | Healthy controls, Obstructive sleep apnea patients |
| Nasal mask with partly blockedObstructive 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 | Healthy controls, Obstructive sleep apnea patients |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Derived from this study: PubMed 33604802An 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.
- Derived from this study: PubMed 31538606An 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.
- Derived from this study: PubMed 30243839An 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Demin Han, MD,PhD study director
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxymetazoline Nasal Spray, Menthol Nasal Spray and Normal saline Nasal Spray in people with Obstructive Sleep Apnea, run by Beijing Tongren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunsong An, MD (8618801119312, anyunsong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-hypopnea Index (time frame: 2 to 6 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03506178, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2018.