Management of Sleep Apnea Patients by a Clinical Nurse (Supernurse)
NCT ID: NCT03455920
Last Updated: 2020-12-10
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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COMPLETED
NA
200 participants
INTERVENTIONAL
2017-12-19
2020-04-30
Brief Summary
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The overall goal of this project is to assess the feasibility and the non-inferiority of integrating a clinical nurse, or supernurse, to the initial consultation team.
The hypothesis is that the integration of a clinical nurse to the sleep clinic's evaluation team is non inferior in terms of patients' outcomes such as improvement of symptoms and quality of life as well as adherence to treatment.
This study is supported by funding dedicated to teaching and research activities related to sleep-disordered breathing.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Multidisciplinary arm
Patients randomized in this group will have their first sleep clinic evaluation with the clinical nurse. She will then discuss each case with the pulmonologist and validate the diagnostic and therapeutic avenue.
Clinical nurse (supernurse) evaluation
The first evaluation of the patient refered to the sleep clinic will be performed by the clinical nurse then discussed with the pulmonologist in charge.
Pulmonologist arm
Patients randomized in this group will have their first sleep clinic evaluation with the pulmonologist.
Pulmonologist evaluation
The first evaluation of the patient refered to the sleep clinic will be performed only by the pulmonologist.
Interventions
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Clinical nurse (supernurse) evaluation
The first evaluation of the patient refered to the sleep clinic will be performed by the clinical nurse then discussed with the pulmonologist in charge.
Pulmonologist evaluation
The first evaluation of the patient refered to the sleep clinic will be performed only by the pulmonologist.
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) between 27-35 kg/m2;
* Apnea-Hypopnea Index (ADI) equal or above 20 events per hour with less than 5 events per hour of central origin;
* Oxygen Desaturaton Index (ODI) equal or above 10 events per hour;
* Percentage of time spent below 90% of oxygen saturation equal or less than 10%
ALL
No
Sponsors
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Laval University
OTHER
Annie C Lajoie
OTHER
Responsible Party
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Annie C Lajoie
MD
Locations
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Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec (CRIUCPQ)
Québec, Quebec, Canada
Countries
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References
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Antic NA, Buchan C, Esterman A, Hensley M, Naughton MT, Rowland S, Williamson B, Windler S, Eckermann S, McEvoy RD. A randomized controlled trial of nurse-led care for symptomatic moderate-severe obstructive sleep apnea. Am J Respir Crit Care Med. 2009 Mar 15;179(6):501-8. doi: 10.1164/rccm.200810-1558OC. Epub 2009 Jan 8.
Chai-Coetzer CL, Antic NA, Rowland LS, Reed RL, Esterman A, Catcheside PG, Eckermann S, Vowles N, Williams H, Dunn S, McEvoy RD. Primary care vs specialist sleep center management of obstructive sleep apnea and daytime sleepiness and quality of life: a randomized trial. JAMA. 2013 Mar 13;309(10):997-1004. doi: 10.1001/jama.2013.1823.
Robertson S, Maxwell C, McGarry GW, MacKenzie K. A nurse-led snoring clinic: how we do it. Clin Otolaryngol. 2009 Apr;34(2):158-61. doi: 10.1111/j.1749-4486.2009.01898.x. No abstract available.
Tomlinson M, John Gibson G. Obstructive sleep apnoea syndrome: a nurse-led domiciliary service. J Adv Nurs. 2006 Aug;55(3):391-7. doi: 10.1111/j.1365-2648.2006.03907.x.
Chai-Coetzer CL, Antic NA, Rowland LS, Catcheside PG, Esterman A, Reed RL, Williams H, Dunn S, McEvoy RD. A simplified model of screening questionnaire and home monitoring for obstructive sleep apnoea in primary care. Thorax. 2011 Mar;66(3):213-9. doi: 10.1136/thx.2010.152801. Epub 2011 Jan 20.
Lajoie AC, Prive A, Roy-Halle A, Page D, Simard S, Series F. Diagnosis and management of sleep apnea by a clinical nurse: a noninferiority randomized clinical trial. J Clin Sleep Med. 2022 Jan 1;18(1):89-97. doi: 10.5664/jcsm.9502.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Sleep Apnea Supernurse
Identifier Type: -
Identifier Source: org_study_id