Hospital santa Maria
Lleida, Catalonia, 25198, Spain
NCT Number: NCT01918449
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Lleida, Catalonia, 25198, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The study evaluates two different setting to follow up patients with obstructive sleep apnea on CPAP treatment
Time frame: Six month
Number of hours of use per day of CPAP according to the internal clock of the CPAP device
Time frame: At baseline and at 6 month of follow-up
Epworth Sleepiness Scale (ESS)
Time frame: Six month
visual analog scale (0-10)
Time frame: Six month
Adverse events related to CPAP treatment
Time frame: Baseline and at 6 month of follow up
EuroQol
Time frame: Six month
Qualys
Time frame: Six month
Charlson index
Time frame: Sixt month
Office blood pressure
Time frame: Six month
Percentage of patients lost during follow up
Time frame: Six month
Sociedad Española de Neumología y Cirugía Torácica
Other
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.
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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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