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OpenTrials
Completed

NCT Number: NCT03455920

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

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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Key information

Conditions

Sleep Apnea Syndromes Apnea Dyssomnias Multidisciplinary Communication Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Québec, Quebec, G1V4G5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Pulmonologist evaluation

Other

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

Primary outcomes

  1. Improvement in symptoms

    Time frame: Assessed at three months

    Based on the Epworth Sleepiness scale (ranging from 0 to 24 points, higher values indicates increased sleepiness)

  2. Improvement in symptoms

    Time frame: Assessed at six months

    Based on the Epworth Sleepiness scale (ranging from 0 to 24 points, higher values indicates increased sleepiness)

Secondary outcomes

  1. Improvement in quality of life

    Time frame: Assessed at three months

    Based on the Quebec Sleep questionnaire

  2. Improvement in quality of life

    Time frame: Assessed at six months

    Based on the Quebec Sleep Questionnaire

  3. Positive pressure treatment adherence

    Time frame: Assessed at six months

    Number of hours used per night according to CPAP report

  4. Mandibular advancement device treatment adherence

    Time frame: Assessed at six months

    According to the patient's usage report

  5. Weight loss treatment adherence

    Time frame: Assessed at six months

    Changes from baseline weight (kg)

  6. Positional therapy

    Time frame: Assessed at six months

    Proportion of time spent supine at baseline and at control cardio-respiratory recording

Sponsors and collaborators

Lead sponsor

Annie C Lajoie

Other

Collaborators

  • Laval University

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 7, 2018
Registry last updated
Dec 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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