Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2017-03-01
2018-06-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
TRIPLE
Study Groups
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PSG with Xylometazoline then placebo
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.
Xylometazoline
Patient will be given a nasal decongestant (Xylometazoline) prior to their 2nd or 3rd night of PSG.
placebo (saline)
Patient will be given a placebo nasal spray (saline) prior to their 2nd or 3rd night of PSG.
PSG with placebo then Xylometazoline
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.
Xylometazoline
Patient will be given a nasal decongestant (Xylometazoline) prior to their 2nd or 3rd night of PSG.
placebo (saline)
Patient will be given a placebo nasal spray (saline) prior to their 2nd or 3rd night of PSG.
Interventions
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Xylometazoline
Patient will be given a nasal decongestant (Xylometazoline) prior to their 2nd or 3rd night of PSG.
placebo (saline)
Patient will be given a placebo nasal spray (saline) prior to their 2nd or 3rd night of PSG.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Lovisenberg Diakonale Hospital
OTHER
Responsible Party
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Principal Investigators
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Søren Berg, MD PhD
Role: STUDY_CHAIR
University of Lund
Locations
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Lovisenberg Diaconal Hospital
Oslo, , Norway
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Hoel 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.
Other Identifiers
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LovisenbergH
Identifier Type: -
Identifier Source: org_study_id
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