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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sleep Apnea Syndromes, Sleep Apnea, Multidisciplinary Communication, Sleep Apnea, Obstructive

Intervention / Treatment
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* Other: Clinical nurse (supernurse) evaluation
* Other: Pulmonologist evaluation


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multidisciplinary arm<br>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<br>* 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.<br>|
| Active Comparator: Pulmonologist arm<br>Patients randomized in this group will have their first sleep clinic evaluation with the pulmonologist. | Other: Pulmonologist evaluation<br>* The first evaluation of the patient refered to the sleep clinic will be performed only by the pulmonologist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in symptoms | Based on the Epworth Sleepiness scale (ranging from 0 to 24 points, higher values indicates increased sleepiness) | Assessed at three months | 
| 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 Outcome Measures

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