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

Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03455920
• Other study ID #: Sleep Apnea Supernurse
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

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

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