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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03455920
Other study ID # Sleep Apnea Supernurse
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 19, 2017
Est. completion date April 30, 2020

Study information

Verified date December 2020
Source Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date April 30, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Canada Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec (CRIUCPQ) Quebec City Quebec

Sponsors (2)

Lead Sponsor Collaborator
Annie C Lajoie Laval University

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View Citation

Tomlinson M, John Gibson G. Obstructive sleep apnoea syndrome: a nurse-led domiciliary service. J Adv Nurs. 2006 Aug;55(3):391-7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement in symptoms Based on the Epworth Sleepiness scale (ranging from 0 to 24 points, higher values indicates increased sleepiness) Assessed at three months
Primary 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 Improvement in quality of life Based on the Quebec Sleep questionnaire Assessed at three months
Secondary Improvement in quality of life Based on the Quebec Sleep Questionnaire Assessed at six months
Secondary Positive pressure treatment adherence Number of hours used per night according to CPAP report Assessed at six months
Secondary Mandibular advancement device treatment adherence According to the patient's usage report Assessed at six months
Secondary Weight loss treatment adherence Changes from baseline weight (kg) Assessed at six months
Secondary Positional therapy Proportion of time spent supine at baseline and at control cardio-respiratory recording Assessed at six months
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