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

Not Applicable

Completed

• Conditions: Sleep Apnea; Sleep Apnea Syndromes; Multidisciplinary Communication; Sleep Apnea, Obstructive
• Interventions: Other: Pulmonologist evaluation; Other: Clinical nurse (supernurse) evaluation

• Registration Number: NCT03455920
• Lead Sponsor: Annie C Lajoie

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-19
• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2018-03-05
• Study First Posted: 2018-03-07
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-09
• Last Update Posted: 2020-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulmonologist arm	Pulmonologist evaluation	Patients randomized in this group will have their first sleep clinic evaluation with the pulmonologist.
Multidisciplinary arm	Clinical nurse (supernurse) evaluation	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec (CRIUCPQ); 🇨🇦 Quebec City, Quebec, Canada