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History of Changes for Study: NCT01918449
Follow-up of Patients With Obstructive Sleep Apnea in Primary Care.
Latest version (submitted November 24, 2014) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 5, 2013 None (earliest Version on record)
2 August 7, 2013 Study Status
3 May 13, 2014 Study Status
4 November 24, 2014 Recruitment Status, Study Status, Contacts/Locations, Arms and Interventions and Study Design
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Study NCT01918449
Submitted Date:  August 5, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: PI12/01499
Brief Title: Follow-up of Patients With Obstructive Sleep Apnea in Primary 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.
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2013
Overall Status: Recruiting
Study Start: January 2013
Primary Completion: December 2013 [Anticipated]
Study Completion: June 2014 [Anticipated]
First Submitted: July 23, 2013
First Submitted that
Met QC Criteria:
August 5, 2013
First Posted: August 7, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 5, 2013
Last Update Posted: August 7, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Sociedad Española de Neumología y Cirugía Torácica
Responsible Party: Principal Investigator
Investigator: Ferran Barbe
Official Title: MD
Affiliation: Sociedad Española de Neumología y Cirugía Torácica
Collaborators: Instituto de Salud Carlos III
Fundacio Catalana de Pneumologia
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.

Detailed Description:
Open or close this module Conditions
Conditions: OSA
Keywords: OSA
CPAP treatment
primary care
efficacy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Supportive Care
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 210 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
No Intervention: Sleep Unit group
This group will have standard follow up in sleep unit at 1, 3 and 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 month. These patients will also be instructed in hygienic-dietary measures, standard care of cardiovascular risk factors and sleep hygiene counseling.
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
Secondary Outcome Measures:
1. Daytime sleepiness
[ Time Frame: At baseline and at 6 month of follow-up ]

Epworth Sleepiness Scale (ESS)
2. Patient satisfaction
[ Time Frame: Six month ]

visual analog scale (0-10)
3. Adverse events
[ Time Frame: Six month ]

Adverse events related to CPAP treatment
4. Quality of life
[ Time Frame: Baseline and at 6 month of follow up ]

EuroQol
5. Cost-efficacy evaluation
[ Time Frame: Six month ]

Qualys
6. Comorbidity index
[ Time Frame: Six month ]

Charlson index
7. Blood pressure
[ Time Frame: Sixt month ]

Office blood pressure
8. Lost of follow up
[ Time Frame: Six month ]

Percentage of patients lost during follow up
Other Outcome Measures:
1. Body mass index
[ Time Frame: Six month ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Men and women over 18 years old.
  • Patients with OSA diagnosis performed in the sleep units
  • Written informed consent signed.

Exclusion Criteria:

  • Previous CPAP treatment for OSA diagnosis
  • Psycho-physical inability to complete questionnaires.
  • Presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivation, regular use of hypnotic or sedative medications and restless leg syndrome
  • Patients with respiratory diseases (overlap syndrome, hypoventilation, restrictive diseases)
  • A medical history that may interfere with the study objectives or, in the opinion of the investigator, compromise the conclusions.
  • Any medical factor, social or geographical, that may jeopardize patient compliance.(e.g., alcohol consumption (more 80 gr/day in men and more than 60 gr / day in women), no fixed address, disorientation, or a history of non-compliance).
Open or close this module Contacts/Locations
Central Contact Person: Ferran Barbe, MD
Telephone: 34973705372
Email: febarbe.lleida.ics@gencat.cat
Central Contact Backup: Cristina Esquinas, RN, MPH
Telephone: 34658865112
Email: crise4@hotmail.com
Study Officials: Ferran Barbe, MD
Study Director
Hospital Anrnau Vilanova- Santa Maria, Lleida (Spain)
Cristina Esquinas, RN, MPH
Principal Investigator
Hospital Arnau Vilanova-Santa Maria, Lleida (Spain)
Nuria Nadal, MD
Principal Investigator
Primary Care. National Health Institute. Lleida (Spain)
Locations: Spain, Catalonia
Hospital santa Maria
[Recruiting]
Lleida, Catalonia, Spain, 25198
Contact:Contact: Cristina Esquinas, RN, MSP 34973705372 crise4@hotmail.com
Contact:Principal Investigator: Ferran Barbe, MD
Contact:Principal Investigator: Cristina Esquinas, RN, MPH
Contact:Sub-Investigator: Manuel Sanchez de la Torre, PhD
Contact:Sub-Investigator: Nuria Nadal, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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