Sleep Apnea SyndromesNCT03455920
Management of Sleep Apnea Patients by a Clinical Nurse (Supernurse)
A study testing Clinical nurse (supernurse) evaluation and Pulmonologist evaluation in people with Sleep Apnea Syndromes and Sleep Apnea, run by Annie C Lajoie at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sleep Apnea Syndromes, Sleep Apnea, Multidisciplinary Communication
- What is being tested?
- Clinical nurse (supernurse) evaluation and Pulmonologist evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 19 Dec 2017to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- Patients not meeting the above inclusion criteria.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec (CRIUCPQ)
Québec, Quebec, G1V4G5
About this study
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
- Being tested
- Clinical nurse (supernurse) evaluation, Pulmonologist evaluation
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical nurse (supernurse) evaluationOther
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 evaluationOther
The first evaluation of the patient refered to the sleep clinic will be performed only by the pulmonologist.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Clinical nurse (supernurse) evaluation |
| Pulmonologist arm | Active comparator | Patients randomized in this group will have their first sleep clinic evaluation with the pulmonologist. Receives: Other: Pulmonologist evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in symptoms
Based on the Epworth Sleepiness scale (ranging from 0 to 24 points, higher values indicates increased sleepiness)
Measured: Assessed at three months
Improvement in symptoms
Based on the Epworth Sleepiness scale (ranging from 0 to 24 points, higher values indicates increased sleepiness)
Measured: Assessed at six months
Secondary outcomes (6)
Improvement in quality of life
Based on the Quebec Sleep questionnaire
Measured: Assessed at three months
Improvement in quality of life
Based on the Quebec Sleep Questionnaire
Measured: Assessed at six months
Positive pressure treatment adherence
Number of hours used per night according to CPAP report
Measured: Assessed at six months
Mandibular advancement device treatment adherence
According to the patient's usage report
Measured: Assessed at six months
Weight loss treatment adherence
Changes from baseline weight (kg)
Measured: Assessed at six months
Positional therapy
Proportion of time spent supine at baseline and at control cardio-respiratory recording
Measured: Assessed at six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start19 Dec 2017
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Annie C Lajoie
- Sponsor type
- University, hospital or other
- Collaborators
- Laval University
- Responsible party
- Sponsor-investigator, Annie C Lajoie, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455920
- Sponsor's protocol ID
- Sleep Apnea Supernurse
- Status last verified
- Dec 2020
- First submitted
- 20 Dec 2017
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19136368Chai-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.
PubMed 23483174Robertson 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.
PubMed 19413617Tomlinson 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.
PubMed 16866834Chai-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.
PubMed 21252389Lajoie 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.
PubMed 34170235
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Sleep Apnea Patients by a Clinical Nurse (Supernurse)
- ClinicalTrials.gov ID
- NCT03455920
- Acronym / sponsor ID
- Sleep Apnea Supernurse
- Conditions
- Sleep Apnea Syndromes, Sleep Apnea, Multidisciplinary Communication, Sleep Apnea, Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Annie C LajoieUniversity, hospital or other
- Collaborators
- Laval University
- Study start
- 19 Dec 2017 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 7 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinary arm | Experimental | Other: Clinical nurse (supernurse) evaluationPatients 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 | Other: Pulmonologist evaluationPatients randomized in this group will have their first sleep clinic evaluation with the pulmonologist. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (1 listed)
- Patients not meeting the above inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical nurse (supernurse) evaluationThe first evaluation of the patient refered to the sleep clinic will be performed by the clinical nurse then discussed with the pulmonologist in charge. | Other | Multidisciplinary arm |
| Pulmonologist evaluationThe first evaluation of the patient refered to the sleep clinic will be performed only by the pulmonologist. | Other | Pulmonologist arm |
Primary outcome
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)
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)
6 secondary outcomes
Improvement in quality of life
Time frame: Assessed at three months
Improvement in quality of life
Time frame: Assessed at six months
Positive pressure treatment adherence
Time frame: Assessed at six months
Mandibular advancement device treatment adherence
Time frame: Assessed at six months
Weight loss treatment adherence
Time frame: Assessed at six months
Positional therapy
Time frame: Assessed at six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Background: PubMed 19136368Antic 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.
- Background: PubMed 23483174Chai-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.
- Background: PubMed 19413617Robertson 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.
- Background: PubMed 16866834Tomlinson 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.
- Background: PubMed 21252389Chai-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.
- Derived from this study: PubMed 34170235Lajoie 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical nurse (supernurse) evaluation and Pulmonologist evaluation in people with Sleep Apnea Syndromes and Sleep Apnea, run by Annie C Lajoie at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in symptoms (time frame: Assessed at three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03455920, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020.