|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT02234765 |
|
Date of registration:
|
02/09/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Management of Patients With Suspected of Sleep Apnea-hypopnea Syndrome From Primary Care
GESAP |
|
Scientific title:
|
Management of Patients With Suspected Sleep Apnea Syndrome From Primary Care: Territorial Assistance Network. |
|
Date of first enrolment:
|
May 2014 |
|
Target sample size:
|
280 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02234765 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Spain
| | | | | | | |
|
Contacts
|
|
Name:
|
Ferran Barbe, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Hospital Arnau de Vilanova. IRB Lleida. CIBERes |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Men and women over 18 years old
- Suspected OSA patients (chronic snoring, apneas, excessive daytime sleepiness) or
resistant hypertension
- Written informed consent signed
Exclusion Criteria:
- Patients with impaired lung function (sd. overlap, obesity hypoventilation, and
restrictive disorders)
- Severe heart failure
- Severe chronic pathology associated
- Psychiatric disorder
- Periodic leg movements
- Pregnancy
- Other dyssomnias or parasomnias
- Patients already treated with CPAP
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Sleep Apnea Syndrome
|
|
Intervention(s)
|
|
Other: Primary Care-based management
|
|
Other: Standard management
|
|
Primary Outcome(s)
|
|
Change from baseline in daytime sleepiness (ESS score) at 6 months
[Time Frame: baseline and 6 months]
|
|
Cost-effectiveness at 6 months
[Time Frame: 6 months]
|
|
Secondary Outcome(s)
|
|
Adverse events at 6 months
[Time Frame: 6 months]
|
|
Change from baseline in quality of life
[Time Frame: baseline and 6 months]
|
|
Change from baseline in blood pressure
[Time Frame: Baseline and 6 months]
|
|
CPAP compliance at 6 months
[Time Frame: 6 months]
|
|
Change from baseline in body mass index
[Time Frame: Baseline and 6 months]
|
|
Lost of follow up / Abandons at 6 months
[Time Frame: 6 months]
|
|
Satisfaction at 6 months
[Time Frame: 6 months]
|
|
Secondary ID(s)
|
|
PI13/02004
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|