Please select the arm or intervention descriptions that belong to the clinical trial below.
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.
Brief Summary: 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.


Options:
A: Arm Label: Domiciliary group; Type: ACTIVE_COMPARATOR; Interventions: Other: Diagnosis and monitoring of OSA patients | Arm Label: Hospital Group; Type: ACTIVE_COMPARATOR; Interventions: Other: Diagnosis and monitoring of OSA patients | Arm Label: Mixed Group; Type: ACTIVE_COMPARATOR; Interventions: Other: Diagnosis and monitoring of OSA patients | Intervention Type: OTHER; Name: Diagnosis and monitoring of OSA patients; Assigned to Arm(s): Domiciliary group, Hospital Group, Mixed Group
B: Arm Label: Usual Care; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Usual care | Arm Label: Self-Management; Type: EXPERIMENTAL; Interventions: Behavioral: Sleep Apnea Self-Management Program | Intervention Type: BEHAVIORAL; Name: Sleep Apnea Self-Management Program; Assigned to Arm(s): Self-Management | Intervention Type: BEHAVIORAL; Name: Usual care; Assigned to Arm(s): Usual Care
C: Arm Label: Enhanced education and Enhanced follow up; Type: EXPERIMENTAL; Interventions: Other: Enhanced education, Other: Usual follow up | Arm Label: Usual education and Usual follow up; Type: ACTIVE_COMPARATOR; Interventions: Other: Usual education, Other: Enhanced follow up | Arm Label: Enhanced education and Usual follow up; Type: EXPERIMENTAL; Interventions: Other: Enhanced education, Other: Enhanced follow up | Arm Label: Usual education with Enhanced follow up; Type: EXPERIMENTAL; Interventions: Other: Usual education, Other: Usual follow up | Intervention Type: OTHER; Name: Enhanced education; Assigned to Arm(s): Enhanced education and Enhanced follow up, Enhanced education and Usual follow up | Intervention Type: OTHER; Name: Usual education; Assigned to Arm(s): Usual education and Usual follow up, Usual education with Enhanced follow up | Intervention Type: OTHER; Name: Usual follow up; Assigned to Arm(s): Enhanced education and Enhanced follow up, Usual education with Enhanced follow up | Intervention Type: OTHER; Name: Enhanced follow up; Assigned to Arm(s): Enhanced education and Usual follow up, Usual education and Usual follow up
D: Arm Label: Sleep Unit group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Primary Care group; Type: EXPERIMENTAL; Interventions: Other: Clinical follow up by general practitioners in primary care | Intervention Type: OTHER; Name: Clinical follow up by general practitioners in primary care; Assigned to Arm(s): Primary Care group

Answer: D