Clinical trial NCT03455920: Management of Sleep Apnea Patients by a Clinical Nurse (Supernurse)
Official title: Management of Sleep Apnea Patients by a Clinical Nurse (Supernurse)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndromes
Sleep Apnea
Multidisciplinary Communication
Sleep Apnea, Obstructive
Lead sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Sponsor class: OTHER
Collaborators: name: Laval University
First posted: 2018-03-07
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sleep apnea is a prevalent problem and references for the evaluation of this condition often exceeds the sleep clinic's capacity thus creating important delays in the patients' care.

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.


Eligibility criteria: Inclusion Criteria:

* Patients referred to the ''Institut Universitaire de Cardiologie et Pneumologie de Québec'' 's sleep clinic who have undergone a cardiorespiratory polygraphy.
* 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%

Exclusion criteria :

- Patients not meeting the above inclusion criteria.

Primary outcomes:
measure: Improvement in symptoms
timeFrame: Assessed at three months
measure: Improvement in symptoms
timeFrame: Assessed at six months
Secondary outcomes:
measure: Improvement in quality of life
timeFrame: Assessed at three months
measure: Improvement in quality of life
timeFrame: Assessed at six months
measure: Positive pressure treatment adherence
timeFrame: Assessed at six months
measure: Mandibular advancement device treatment adherence
timeFrame: Assessed at six months
measure: Weight loss treatment adherence
timeFrame: Assessed at six months
measure: Positional therapy
timeFrame: Assessed at six months
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec (CRIUCPQ)
state: Quebec
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.