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The Role of the Nose in Snoring and Sleep Apnea

Primary Purpose

Nasal Obstruction, Apnea, Obstructive Sleep

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Xylometazoline
placebo (saline)
Sponsored by
Lovisenberg Diakonale Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Nasal Obstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Lovisenberg Diaconal HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PSG with Xylometazoline then placebo

PSG with placebo then Xylometazoline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Level in therapeutic CPAP pressure
Therapeutic CPAP pressure levels are measured automatically in CPAP device

Secondary Outcome Measures

Full Information

First Posted
March 2, 2017
Last Updated
March 6, 2017
Sponsor
Lovisenberg Diakonale Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03072173
Brief Title
The Role of the Nose in Snoring and Sleep Apnea
Official Title
The Role of the Nose in Snoring and Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lovisenberg Diakonale Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Obstruction, Apnea, Obstructive Sleep

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PSG with Xylometazoline then placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
PSG with placebo then Xylometazoline
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Xylometazoline
Intervention Description
Patient will be given a nasal decongestant (Xylometazoline) prior to their 2nd or 3rd night of PSG.
Intervention Type
Drug
Intervention Name(s)
placebo (saline)
Intervention Description
Patient will be given a placebo nasal spray (saline) prior to their 2nd or 3rd night of PSG.
Primary Outcome Measure Information:
Title
Level in therapeutic CPAP pressure
Description
Therapeutic CPAP pressure levels are measured automatically in CPAP device
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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%)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hans Christian Hoel, MD
Phone
004792825316
Email
hans.hoel@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Søren Berg, MD PhD
Phone
004528688887
Email
sb@bergshallan.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Søren Berg, MD PhD
Organizational Affiliation
University of Lund
Official's Role
Study Chair
Facility Information:
Facility Name
Lovisenberg Diaconal Hospital
City
Oslo
ZIP/Postal Code
0456
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anners Lerdal, PhD
Phone
004795033144
Email
Anners.Lerdal@lds.no

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32502854
Citation
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.
Results Reference
derived

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The Role of the Nose in Snoring and Sleep Apnea

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