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The Role of the Nose in Snoring and Sleep Apnea

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ClinicalTrials.gov Identifier: NCT03072173
Recruitment Status : Recruiting
First Posted : March 7, 2017
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Lovisenberg Diakonale Hospital

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Nasal Obstruction Apnea, Obstructive Sleep Drug: Xylometazoline Drug: placebo (saline) Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: The Role of the Nose in Snoring and Sleep Apnea
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea Snoring

Arm Intervention/treatment
Experimental: 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.

Drug: Xylometazoline
Patient will be given a nasal decongestant (Xylometazoline) prior to their 2nd or 3rd night of PSG.

Drug: placebo (saline)
Patient will be given a placebo nasal spray (saline) prior to their 2nd or 3rd night of PSG.

Experimental: 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.

Drug: Xylometazoline
Patient will be given a nasal decongestant (Xylometazoline) prior to their 2nd or 3rd night of PSG.

Drug: placebo (saline)
Patient will be given a placebo nasal spray (saline) prior to their 2nd or 3rd night of PSG.




Primary Outcome Measures :
  1. Level in therapeutic CPAP pressure [ Time Frame: 6 months ]
    Therapeutic CPAP pressure levels are measured automatically in CPAP device



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with manifest OSAS and in need of CPAP-treatment

Exclusion Criteria:

  • Not speaking Norwegian Language, Congestive heart failure (ejection fraction <40%)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03072173


Contacts
Contact: Hans Christian Hoel, MD 004792825316 hans.hoel@gmail.com
Contact: Søren Berg, MD PhD 004528688887 sb@bergshallan.dk

Locations
Norway
Lovisenberg Diaconal Hospital Recruiting
Oslo, Norway, 0456
Contact: Anners Lerdal, PhD    004795033144    Anners.Lerdal@lds.no   
Sponsors and Collaborators
Lovisenberg Diakonale Hospital
Investigators
Study Chair: Søren Berg, MD PhD University of Lund

Responsible Party: Lovisenberg Diakonale Hospital
ClinicalTrials.gov Identifier: NCT03072173     History of Changes
Other Study ID Numbers: LovisenbergH
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Apnea
Sleep Apnea, Obstructive
Snoring
Nasal Obstruction
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Apnea Syndromes
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Respiratory Sounds
Nose Diseases
Airway Obstruction
Respiratory Insufficiency
Otorhinolaryngologic Diseases
Xylometazoline
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents