Management of Sleep Apnea Patients by a Clinical Nurse (Supernurse)
Primary Purpose
Sleep Apnea Syndromes, Sleep Apnea, Multidisciplinary Communication
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Clinical nurse (supernurse) evaluation
Pulmonologist evaluation
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea Syndromes
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.
Sites / Locations
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec (CRIUCPQ)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Multidisciplinary arm
Pulmonologist arm
Arm Description
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.
Patients randomized in this group will have their first sleep clinic evaluation with the pulmonologist.
Outcomes
Primary Outcome Measures
Improvement in symptoms
Based on the Epworth Sleepiness scale (ranging from 0 to 24 points, higher values indicates increased sleepiness)
Improvement in symptoms
Based on the Epworth Sleepiness scale (ranging from 0 to 24 points, higher values indicates increased sleepiness)
Secondary Outcome Measures
Improvement in quality of life
Based on the Quebec Sleep questionnaire
Improvement in quality of life
Based on the Quebec Sleep Questionnaire
Positive pressure treatment adherence
Number of hours used per night according to CPAP report
Mandibular advancement device treatment adherence
According to the patient's usage report
Weight loss treatment adherence
Changes from baseline weight (kg)
Positional therapy
Proportion of time spent supine at baseline and at control cardio-respiratory recording
Full Information
NCT ID
NCT03455920
First Posted
December 20, 2017
Last Updated
December 9, 2020
Sponsor
Annie C Lajoie
Collaborators
Laval University
1. Study Identification
Unique Protocol Identification Number
NCT03455920
Brief Title
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
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 19, 2017 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Annie C Lajoie
Collaborators
Laval University
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes, Sleep Apnea, Multidisciplinary Communication, Sleep Apnea, Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multidisciplinary arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Pulmonologist arm
Arm Type
Active Comparator
Arm Description
Patients randomized in this group will have their first sleep clinic evaluation with the pulmonologist.
Intervention Type
Other
Intervention Name(s)
Clinical nurse (supernurse) evaluation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pulmonologist evaluation
Intervention Description
The first evaluation of the patient refered to the sleep clinic will be performed only by the pulmonologist.
Primary Outcome Measure Information:
Title
Improvement in symptoms
Description
Based on the Epworth Sleepiness scale (ranging from 0 to 24 points, higher values indicates increased sleepiness)
Time Frame
Assessed at three months
Title
Improvement in symptoms
Description
Based on the Epworth Sleepiness scale (ranging from 0 to 24 points, higher values indicates increased sleepiness)
Time Frame
Assessed at six months
Secondary Outcome Measure Information:
Title
Improvement in quality of life
Description
Based on the Quebec Sleep questionnaire
Time Frame
Assessed at three months
Title
Improvement in quality of life
Description
Based on the Quebec Sleep Questionnaire
Time Frame
Assessed at six months
Title
Positive pressure treatment adherence
Description
Number of hours used per night according to CPAP report
Time Frame
Assessed at six months
Title
Mandibular advancement device treatment adherence
Description
According to the patient's usage report
Time Frame
Assessed at six months
Title
Weight loss treatment adherence
Description
Changes from baseline weight (kg)
Time Frame
Assessed at six months
Title
Positional therapy
Description
Proportion of time spent supine at baseline and at control cardio-respiratory recording
Time Frame
Assessed at six months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec (CRIUCPQ)
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V4G5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19136368
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.
Results Reference
background
PubMed Identifier
23483174
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.
Results Reference
background
PubMed Identifier
19413617
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.
Results Reference
background
PubMed Identifier
16866834
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.
Results Reference
background
PubMed Identifier
21252389
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.
Results Reference
background
PubMed Identifier
34170235
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.
Results Reference
derived
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Management of Sleep Apnea Patients by a Clinical Nurse (Supernurse)
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