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| Name | Class |
|---|---|
| Laval University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multidisciplinary arm | Experimental | 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. |
|
| Pulmonologist arm | Active Comparator | Patients randomized in this group will have their first sleep clinic evaluation with the pulmonologist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical nurse (supernurse) evaluation | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion criteria :
- Patients not meeting the above inclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec (CRIUCPQ) | Québec | Quebec | G1V4G5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19136368 | Background | 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. | |
| 23483174 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 12, 2018 | Mar 5, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| Pulmonologist evaluation | Other | The first evaluation of the patient refered to the sleep clinic will be performed only by the pulmonologist. |
|
| 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 |
| 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. |
| 19413617 | Background | 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. |
| 16866834 | Background | 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. |
| 21252389 | Background | 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. |
| 34170235 | Derived | 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. |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |