A new tool for screening severe sleep apnea syndrome
| ISRCTN | ISRCTN13617639 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13617639 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 2212434 |
| Sponsor | Clinique Pasteur |
| Funder | Clinique Pasteur |
- Submission date
- 19/03/2019
- Registration date
- 22/03/2019
- Last edited
- 22/03/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aim
Obstructive sleep apnea syndrome (OSAS) affects nearly one billion people worldwide. Specific screening tools are not available to identify OSAS in nocturnal polyuria (NP) populations. To develop a screening tool for detecting severe OSAS in patients presenting with NP.
Who can participate?
Men aged over 18 years who have nocturia due to nocturnal polyuria
What does the study involve?
This is a retrospective review of patients diagnosed with nocturia due to nocturnal polyuria and screened for obstructive sleep apnea syndrome between 2016 and 2018. The researchers gathered data about the collection of data, the characteristic of patients and their follow up. This is done to develop a screening tool for detecting severe OSAS in patients presenting with nocturnal polyuria.
What are the possible benefits and risks of participating?
There are no benefits or risks for participating.
Where is the study run from?
Clinique Pasteur, Toulouse
When is the study starting and how long is it expected to run for?
January 2016 to December 2018.
Who is funding the study?
The Clinique Pasteur
Who is the main contact?
Dr Vincent Misrai
vmisrai@clinique-pasteur.com
Contact information
Scientific
Clinique Pasteur
45, avenue de Lombez
Toulouse
31300
France
| 0000-0003-2029-0650 | |
| Phone | +33562211652 |
| vmisrai@clinique-pasteur.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | A tool for severe obstructive sleep apnea syndrome screening in patients with unexplained nocturnal polyuria |
| Study objectives | Obstructive sleep apnea syndrome (OSAS) affects nearly one billion people worldwide. Specific screening tools are not available to identify OSAS in nocturnal polyuria (NP) populations. Our aim was to develop a screening tool for detecting severe OSAS using a large single-institutional dataset of patients referred for nocturnal polyuria. |
| Ethics approval(s) | Approved 17/01/2016, Commission nationale de l'informatique et des libertés (CNIL, 3 Place de Fontenoy, TSA 80715, 75334 PARIS CEDEX 07, France; +33(0)153732222), ref: 2212434 |
| Health condition(s) or problem(s) studied | Nocturia |
| Intervention | Medical records of patients diagnosed with nocturia due to nocturnal polyuria and screened for obstructive sleep apnea syndrome (OSAS) with a sleep study (overnight polygraphy) Patients diagnosed with severe OSAS were compared to a group of patients without OSAS or diagnosed with mild to moderate OSAS. Clinical predictive factors associated with severe OSAS were identified via logistic regression. A score combining the main predictors was created and evaluated. |
| Intervention type | Other |
| Primary outcome measure(s) |
To design and validate a new “score” (the Clinique Pasteur score) to detect severe OSAS in patients with unexplained nocturnal polyuria. |
| Key secondary outcome measure(s) |
To validate this “score” (internal validation) |
| Completion date | 31/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | 1. Diagnosed with a nocturia due to nocturnal polyuria 2. Screened for sleep apnea syndrome with overnight polygraphy |
| Key exclusion criteria | 1. Patients presenting with the following potential causes of nocturnal polyuria: 1.1 Diabetes insipidus 1.2 Uncontrolled diabetes mellitus (defined by a serum glucose level > 200 mg/dL) 1.3 Severe renal impairment (defined by a glomerular filtration rate of <30 ml/min) 1.4 Hart failure 1.5 Oedematous state |
| Date of first enrolment | 21/01/2016 |
| Date of final enrolment | 31/12/2018 |
Locations
Countries of recruitment
- France
Study participating centre
Toulouse
31300
France
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
22/03/2019: Trial’s existence confirmed by funder