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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
Sponsor:
Collaborators:
Instituto de Salud Carlos III
Fundacio Catalana de Pneumologia
Information provided by (Responsible Party):
Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica

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.


Condition or disease Intervention/treatment Phase
OSA Other: Clinical follow up by general practitioners in primary care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

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


Locations
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Spain
Hospital santa Maria
Lleida, Catalonia, Spain, 25198
Sponsors and Collaborators
Sociedad Española de Neumología y Cirugía Torácica
Instituto de Salud Carlos III
Fundacio Catalana de Pneumologia
Investigators
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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)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ferran Barbe, MD, Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier: NCT01918449     History of Changes
Other Study ID Numbers: PI12/01499
First Posted: August 7, 2013    Key Record Dates
Last Update Posted: November 25, 2014
Last Verified: November 2014
Keywords provided by Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica:
OSA
CPAP treatment
primary care
efficacy