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CompletedNCT03455920Updated Dec 10, 2020

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

An interventional study of Clinical nurse (supernurse) evaluation and Pulmonologist evaluation in Sleep Apnea Syndromes, Sleep Apnea and Multidisciplinary Communication, sponsored by Annie C Lajoie. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2020-12-10.

Sponsored by Annie C Lajoie · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Sleep Apnea Syndromes
  • Sleep Apnea
  • Multidisciplinary Communication
  • Sleep Apnea, Obstructive
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion criteria :

  • Patients not meeting the above inclusion criteria.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • 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

  • Active comparator
    Pulmonologist arm

    Patients randomized in this group will have their first sleep clinic evaluation with the pulmonologist.

    Other: Pulmonologist evaluation

Interventions

  • OtherClinical 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.

  • OtherPulmonologist evaluation

    The first evaluation of the patient refered to the sleep clinic will be performed only by the pulmonologist.

05

What researchers measure

Primary outcomes

  1. Improvement in symptoms

    Based on the Epworth Sleepiness scale (ranging from 0 to 24 points, higher values indicates increased sleepiness)

    Time frame: Assessed at three months

  2. Improvement in symptoms

    Based on the Epworth Sleepiness scale (ranging from 0 to 24 points, higher values indicates increased sleepiness)

    Time frame: Assessed at six months

Secondary outcomes

  1. Improvement in quality of life

    Based on the Quebec Sleep questionnaire

    Time frame: Assessed at three months

  2. Improvement in quality of life

    Based on the Quebec Sleep Questionnaire

    Time frame: Assessed at six months

  3. Positive pressure treatment adherence

    Number of hours used per night according to CPAP report

    Time frame: Assessed at six months

  4. Mandibular advancement device treatment adherence

    According to the patient's usage report

    Time frame: Assessed at six months

  5. Weight loss treatment adherence

    Changes from baseline weight (kg)

    Time frame: Assessed at six months

  6. Positional therapy

    Proportion of time spent supine at baseline and at control cardio-respiratory recording

    Time frame: Assessed at six months

06

Study locations

1 site
  • Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec (CRIUCPQ)
    Quebec City, Quebec G1V4G5, Canada
07

References and documents

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. PubMed 19136368 ↗
  • 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. PubMed 23483174 ↗
  • 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. PubMed 19413617 ↗
  • 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. PubMed 16866834 ↗
  • 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. PubMed 21252389 ↗
  • 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. PubMed 34170235 ↗

Study documents

  • Protocol and statistical analysis plan · Jan 12, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03455920
Lead sponsor
Annie C Lajoie
Collaborators
Laval University
Responsible party
Annie C Lajoie (MD, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec) — Sponsor-investigator
First posted
Mar 7, 2018
Start date
Dec 19, 2017
Primary completion
Apr 30, 2020
Completion
Apr 30, 2020
Last update
Dec 10, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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