The Role of the Nose in Snoring and Sleep Apnea
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 2, 2017
CompletedFirst Posted
Study publicly available on registry
March 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedMarch 7, 2017
February 1, 2017
1.3 years
March 2, 2017
March 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Level in therapeutic CPAP pressure
Therapeutic CPAP pressure levels are measured automatically in CPAP device
6 months
Study Arms (2)
PSG with Xylometazoline then placebo
EXPERIMENTALPatients 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
EXPERIMENTALPatients 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.
Interventions
Patient will be given a nasal decongestant (Xylometazoline) prior to their 2nd or 3rd night of PSG.
Patient will be given a placebo nasal spray (saline) prior to their 2nd or 3rd night of PSG.
Eligibility Criteria
You may qualify if:
- Patients with manifest OSAS and in need of CPAP-treatment
You may not qualify if:
- Not speaking Norwegian Language, Congestive heart failure (ejection fraction \<40%)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lovisenberg Diaconal Hospital
Oslo, 0456, Norway
Related Publications (2)
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.
PMID: 36791622DERIVEDHoel 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.
PMID: 32502854DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Søren Berg, MD PhD
University of Lund
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2017
First Posted
March 7, 2017
Study Start
March 1, 2017
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
March 7, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share