Management of Sleep Apnea Patients by a Clinical Nurse (Supernurse)

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Apnea; Multidisciplinary Communication
• Intervention / Treatment: Other: Clinical nurse (supernurse) evaluation; Other: Pulmonologist evaluation

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Quebec City, Quebec, Canada, G1V4G5
      • Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Active Comparator: Pulmonologist arm; Patients randomized in this group will have their first sleep clinic evaluation with the pulmonologist.	Other: Pulmonologist evaluation; The first evaluation of the patient refered to the sleep clinic will be performed only by the pulmonologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in symptoms	Based on the Epworth Sleepiness scale (ranging from 0 to 24 points, higher values indicates increased sleepiness)	Assessed at three months
Improvement in symptoms	Based on the Epworth Sleepiness scale (ranging from 0 to 24 points, higher values indicates increased sleepiness)	Assessed at six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in quality of life	Based on the Quebec Sleep questionnaire	Assessed at three months
Improvement in quality of life	Based on the Quebec Sleep Questionnaire	Assessed at six months
Positive pressure treatment adherence	Number of hours used per night according to CPAP report	Assessed at six months
Mandibular advancement device treatment adherence	According to the patient's usage report	Assessed at six months
Weight loss treatment adherence	Changes from baseline weight (kg)	Assessed at six months
Positional therapy	Proportion of time spent supine at baseline and at control cardio-respiratory recording	Assessed at six months

Collaborators and Investigators

• Sponsor: Annie C Lajoie
• Collaborators: Laval University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2017
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: March 5, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): December 10, 2020
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: Sleep Apnea Supernurse

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No