Nasal ObstructionNCT03072173
The Role of the Nose in Snoring and Sleep Apnea
A study testing Xylometazoline in people with Nasal Obstruction and Apnea, Obstructive Sleep, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
Trial summary
We intend to study, in depth, the quantitative and qualitative properties of nasal respiration in sleep-disordered breathing and sleep apnea and its relation to (CPAP) treatment with the final goal of improving patient outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Obstruction, Apnea, Obstructive Sleep
- What is being tested?
- Xylometazoline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2017to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with manifest OSAS and in need of CPAP-treatment
Who cannot join
- Not speaking Norwegian Language, Congestive heart failure (ejection fraction <40%)
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Lovisenberg Diaconal Hospital
Oslo, 0456
Anners Lerdal, PhD, 004795033144, Anners.Lerdal@lds.no
About this study
We intend to study, in depth, the quantitative and qualitative properties of nasal respiration in sleep-disordered breathing and sleep apnea and its relation to (CPAP) treatment with the final goal of improving patient outcome.
To do this we will temporarily alter patients' nasal airflow during monitored sleep to lower CPAP air pressure, making CPAP treatment more acceptable to the patient. Additionally we plan to implement highly advanced computerized modelling in collaboration with the OSASMOD research consortium at St. Olavs Hospital/NTNU and SINTEF to predict the results of our alterations and ultimately, to use these predictions to improve both the planning and the outcomes of nasal surgery.
Read the detailed description
Based on results from previous studies we hypothesize that the nose plays a more significant role in normal sleep respiration and in particular a larger role in sleep disordered breathing than previously recorded.
The overall aim of this project is to gain insight into nasal respiration during wake and sleep, its anatomy, physiology and pathophysiology.
Additionally, we will look at olfactory dysfunction, or reduced sense of smell, a known problem in OSAS patients (n=30), and try to determine if this dysfunction has to do with disturbed sleep architecture or as a result of frequent deoxygenations during the night.
To do this we propose to implement current diagnostic tools available in the diagnostics of sleep disordered breathing such as polysomnography (PSG), in combination with rhinological investigations with 4-phase rhinomanometry and techniques such as two-way fluid structure interaction (FSI) computational fluid dynamic (CFD) analysis of patients. For olfactory testing we will use standardized smell tests. These examinations in combination will give us a more detailed view of the factors that influence nasal respiration.
Additionally, we will use an interventional approach in the proposed study. Patient nasal resistance will be modified under monitored sleep by implementing conventional decongestant nasal spray in an double blinded RCT in order to study the effect of varying nasal resistance on nocturnal respiration and sleep architecture.
Findings, where applicable, will be compared with two-way fluid structure interaction computational fluid dynamic models of patients in all studies to find correlative values and thus assess the predicative value of such computer models.
In the short term these findings could improve patient adherence to CPAP by lowering CPAP pressure. Long term aims are to improve the accuracy of nasal surgery.
Potential end points in our research are as follows:
A better understanding of nasal respiration as a whole Better treatment adherence and satisfaction in sleep apnea patients Improved treatment strategies for sleep apnea patients Improved diagnostics of nasal airflow pathology More focused targeting of medical and surgical intervention in impaired nasal airflow
- Conditions
- Nasal Obstruction, Apnea, Obstructive Sleep
- Being tested
- Xylometazoline, placebo (saline)
- Medical subject headings
- Nasal Obstruction, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XylometazolineDrug
Patient will be given a nasal decongestant (Xylometazoline) prior to their 2nd or 3rd night of PSG.
placebo (saline)Drug
Patient will be given a placebo nasal spray (saline) prior to their 2nd or 3rd night of PSG.
| Study group | Role | What they receive |
|---|---|---|
| PSG with Xylometazoline then placebo | Experimental | Patients are administered nasal CPAP with humidifier prior to PSG
Patients in this arm receive Xylometazoline on night 2 of PSG and placebo on night 3 of PSG. Receives: Drug: Xylometazoline; Drug: placebo (saline) |
| PSG with placebo then Xylometazoline | Experimental | Patients are administered nasal CPAP with humidifier prior to PSG
Patients in this arm receive placebo on night 2 of PSG and Xylometazoline on night 3 of PSG. Receives: Drug: Xylometazoline; Drug: placebo (saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level in therapeutic CPAP pressure
Therapeutic CPAP pressure levels are measured automatically in CPAP device
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start1 Mar 2017
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nasal ObstructionStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lovisenberg Diakonale Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Søren Berg, MD PhD, Study chair, University of Lund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072173
- Sponsor's protocol ID
- LovisenbergH
- Status last verified
- Feb 2017
- First submitted
- 2 Mar 2017
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoel HC, Kvinnesland K, Berg S. Outcome of nasal measurements in patients with OSA - Mounting evidence of a nasal endotype. Sleep Med. 2023 Mar;103:131-137. doi: 10.1016/j.sleep.2023.01.028. Epub 2023 Feb 3.
PubMed 36791622Hoel HC, Kvinnesland K, Berg S. Impact of nasal resistance on the distribution of apneas and hypopneas in obstructive sleep apnea. Sleep Med. 2020 Jul;71:83-88. doi: 10.1016/j.sleep.2020.03.024. Epub 2020 Apr 17.
PubMed 32502854
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Nose in Snoring and Sleep Apnea
- ClinicalTrials.gov ID
- NCT03072173
- Acronym / sponsor ID
- LovisenbergH
- Conditions
- Nasal Obstruction, Apnea, Obstructive Sleep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Lovisenberg Diakonale HospitalUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 7 Mar 2017 (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.
We intend to study, in depth, the quantitative and qualitative properties of nasal respiration in sleep-disordered breathing and sleep apnea and its relation to (CPAP) treatment with the final goal of improving patient outcome.
To do this we will temporarily alter patients' nasal airflow during monitored sleep to lower CPAP air pressure, making CPAP treatment more acceptable to the patient. Additionally we plan to implement highly advanced computerized modelling in collaboration with the OSASMOD research consortium at St. Olavs Hospital/NTNU and SINTEF to predict the results of our alterations and ultimately, to use these predictions to improve both the planning and the outcomes of nasal surgery.
Detailed description
Based on results from previous studies we hypothesize that the nose plays a more significant role in normal sleep respiration and in particular a larger role in sleep disordered breathing than previously recorded.
The overall aim of this project is to gain insight into nasal respiration during wake and sleep, its anatomy, physiology and pathophysiology.
Additionally, we will look at olfactory dysfunction, or reduced sense of smell, a known problem in OSAS patients (n=30), and try to determine if this dysfunction has to do with disturbed sleep architecture or as a result of frequent deoxygenations during the night.
To do this we propose to implement current diagnostic tools available in the diagnostics of sleep disordered breathing such as polysomnography (PSG), in combination with rhinological investigations with 4-phase rhinomanometry and techniques such as two-way fluid structure interaction (FSI) computational fluid dynamic (CFD) analysis of patients. For olfactory testing we will use standardized smell tests. These examinations in combination will give us a more detailed view of the factors that influence nasal respiration.
Additionally, we will use an interventional approach in the proposed study. Patient nasal resistance will be modified under monitored sleep by implementing conventional decongestant nasal spray in an double blinded RCT in order to study the effect of varying nasal resistance on nocturnal respiration and sleep architecture.
Findings, where applicable, will be compared with two-way fluid structure interaction computational fluid dynamic models of patients in all studies to find correlative values and thus assess the predicative value of such computer models.
In the short term these findings could improve patient adherence to CPAP by lowering CPAP pressure. Long term aims are to improve the accuracy of nasal surgery.
Potential end points in our research are as follows:
A better understanding of nasal respiration as a whole Better treatment adherence and satisfaction in sleep apnea patients Improved treatment strategies for sleep apnea patients Improved diagnostics of nasal airflow pathology More focused targeting of medical and surgical intervention in impaired nasal airflow
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSG with Xylometazoline then placebo | Experimental | Drug: Xylometazoline, Drug: placebo (saline)Patients are administered nasal CPAP with humidifier prior to PSG Patients in this arm receive Xylometazoline on night 2 of PSG and placebo on night 3 of PSG. |
| PSG with placebo then Xylometazoline | Experimental | Drug: Xylometazoline, Drug: placebo (saline)Patients are administered nasal CPAP with humidifier prior to PSG Patients in this arm receive placebo on night 2 of PSG and Xylometazoline on night 3 of PSG. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with manifest OSAS and in need of CPAP-treatment
Key exclusion criteria (1 listed)
- Not speaking Norwegian Language, Congestive heart failure (ejection fraction <40%)
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 |
|---|---|---|
| XylometazolinePatient will be given a nasal decongestant (Xylometazoline) prior to their 2nd or 3rd night of PSG. | Drug | PSG with Xylometazoline then placebo, PSG with placebo then Xylometazoline |
| placebo (saline)Patient will be given a placebo nasal spray (saline) prior to their 2nd or 3rd night of PSG. | Drug | PSG with Xylometazoline then placebo, PSG with placebo then Xylometazoline |
Primary outcome
Level in therapeutic CPAP pressure
Time frame: 6 months
Therapeutic CPAP pressure levels are measured automatically in CPAP device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Derived from this study: PubMed 36791622Hoel HC, Kvinnesland K, Berg S. Outcome of nasal measurements in patients with OSA - Mounting evidence of a nasal endotype. Sleep Med. 2023 Mar;103:131-137. doi: 10.1016/j.sleep.2023.01.028. Epub 2023 Feb 3.
- Derived from this study: PubMed 32502854Hoel HC, Kvinnesland K, Berg S. Impact of nasal resistance on the distribution of apneas and hypopneas in obstructive sleep apnea. Sleep Med. 2020 Jul;71:83-88. doi: 10.1016/j.sleep.2020.03.024. Epub 2020 Apr 17.
- Individual participant dataSharing planned: No
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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.
Søren Berg, MD PhD study chair
University of Lund
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xylometazoline in people with Nasal Obstruction and Apnea, Obstructive Sleep, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
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 1 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 7 Mar 2017. 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 Norway. 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 Hans Christian Hoel, MD (004792825316, hans.hoel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level in therapeutic CPAP pressure (time frame: 6 months). 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 NCT03072173, which also lists 2 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 7 Mar 2017.