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

NCT03455920 | Completed

• 1 other identifier: Sleep Apnea Supernurse
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea Syndromes; Sleep Apnea; Multidisciplinary Communication; Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Improvement in quality of life

  Assessed at three months

• Improvement in quality of life

  Assessed at six months

• Positive pressure treatment adherence

  Assessed at six months

• Mandibular advancement device treatment adherence

  Assessed at six months

• Weight loss treatment adherence

  Assessed at six months

Study Arms (2)

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.

Other: Clinical nurse (supernurse) evaluation

Pulmonologist arm

ACTIVE COMPARATOR

Patients randomized in this group will have their first sleep clinic evaluation with the pulmonologist.

Other: Pulmonologist evaluation

Interventions

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.

Multidisciplinary arm

Pulmonologist evaluation OTHER

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

Pulmonologist arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

Sponsors & Collaborators

• Annie C Lajoie: lead
• Laval University: collaborator

Study Sites (1)

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec (CRIUCPQ)

Québec, Quebec, G1V4G5, Canada

Location

Related Publications (6)

• 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.

  PMID: 19136368 BACKGROUND

• 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.

  PMID: 23483174 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.

  PMID: 19413617 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.

  PMID: 16866834 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.

  PMID: 21252389 BACKGROUND

• 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.

  PMID: 34170235 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: March 7, 2018
• Study Start: December 19, 2017
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: December 10, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)