Follow-up of Patients With Obstructive Sleep Apnea in Primary Care.
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|ClinicalTrials.gov Identifier: NCT01918449|
Recruitment Status : Completed
First Posted : August 7, 2013
Last Update Posted : November 25, 2014
The objective of the study is to compare the results of a coordinated and interactive program for the treatment, monitoring and control of patients with a moderate-severe diagnosis of Obstructive Sleep Apnea (OSA) and treated with positive continuous pressure (CPAP), with the currently established situation.
Methodology: Equivalence randomized comparative study . It will include patients with diagnosis of moderate-severe OSA (apnea-hypopnea Index >=15) that should start treatment with (CPAP). Participating center is Hospital Santa María-Arnau de Vilanova in Lleida (Spain).These patients will be randomized to two monitoring groups (1: monitoring in the Sleep disorders unit, 2: monitoring in primary care consultations) once the OSAS diagnosis has been made and it was indicated that treatment with CPAP. Patients Will be carried out in both groups the same follow-up visits in two study arms: basal, 1 month, 3 months and 6 months. Primary outcomes: number of hours of use per day (according to the accountant of the CPAP), so that use >= 4h/day is defined as good adherence to the treatment. Secondary outcomes: daytime sleepiness, patient satisfaction, Adverse events related to CPAP treatment. It will be collected demographic ,clinics and anthropometric variables. At the end of follow-up primary and secondary outcomes will be compared between two groups.
|Condition or disease||Intervention/treatment||Phase|
|OSA||Other: Clinical follow up by general practitioners in primary care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Follow-up of Patients With the Apnea-hypopnea Syndrome in Primary Care and Sleep Disorders Units. Equivalence Randomized Comparative Study on Compliance and Clinical Response.|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||June 2014|
No Intervention: Sleep Unit group
This group will have standard follow up in sleep unit at 1, 3 and 6 month. These patients will also be instructed in hygienic-dietary measures, standard care of cardiovascular risk factors and sleep hygiene counseling.
Experimental: Primary Care group
This group will have standard follow up in primary care at 1, 3 and 6 month. These patients will also be instructed in hygienic-dietary measures, standard care of cardiovascular risk factors and sleep hygiene counseling.
Other: Clinical follow up by general practitioners in primary care
The study evaluates two different setting to follow up patients with obstructive sleep apnea on CPAP treatment
- Number of hours of use per day of CPAP [ Time Frame: Six month ]Number of hours of use per day of CPAP according to the internal clock of the CPAP device
- Daytime sleepiness [ Time Frame: At baseline and at 6 month of follow-up ]Epworth Sleepiness Scale (ESS)
- Patient satisfaction [ Time Frame: Six month ]visual analog scale (0-10)
- Adverse events [ Time Frame: Six month ]Adverse events related to CPAP treatment
- Quality of life [ Time Frame: Baseline and at 6 month of follow up ]EuroQol
- Cost-efficacy evaluation [ Time Frame: Six month ]Qualys
- Comorbidity index [ Time Frame: Six month ]Charlson index
- Blood pressure [ Time Frame: Sixt month ]Office blood pressure
- Lost of follow up [ Time Frame: Six month ]Percentage of patients lost during follow up
- Body mass index [ Time Frame: Six month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01918449
|Hospital santa Maria|
|Lleida, Catalonia, Spain, 25198|
|Study Director:||Ferran Barbe, MD||Hospital Anrnau Vilanova- Santa Maria, Lleida (Spain)|
|Principal Investigator:||Cristina Esquinas, RN, MPH||Hospital Arnau Vilanova-Santa Maria, Lleida (Spain)|
|Principal Investigator:||Nuria Nadal, MD||Primary Care. National Health Institute. Lleida (Spain)|