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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

Tracking Information
First Submitted Date  ICMJE July 23, 2013
First Posted Date  ICMJE August 7, 2013
Last Update Posted Date November 25, 2014
Study Start Date  ICMJE January 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2013)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 5, 2013)
Body mass index [ Time Frame: Six month ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Follow-up of Patients With Obstructive Sleep Apnea in Primary Care.
Official Title  ICMJE 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE OSA
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Other: Clinical follow up by general practitioners in primary care
Publications * Sanchez-de-la-Torre M, Nadal N, Cortijo A, Masa JF, Duran-Cantolla J, Valls J, Serra S, Sanchez-de-la-Torre A, Gracia M, Ferrer F, Lorente I, Urgeles MC, Alonso T, Fuentes A, Armengol F, Lumbierres M, Vazquez-Polo FJ, Barbe F; Respiratory Medicine Research Group. Role of primary care in the follow-up of patients with obstructive sleep apnoea undergoing CPAP treatment: a randomised controlled trial. Thorax. 2015 Apr;70(4):346-52. doi: 10.1136/thoraxjnl-2014-206287.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 5, 2013)
210
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01918449
Other Study ID Numbers  ICMJE PI12/01499
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sociedad Española de Neumología y Cirugía Torácica
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Instituto de Salud Carlos III
  • Fundacio Catalana de Pneumologia
Investigators  ICMJE
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)
PRS Account Sociedad Española de Neumología y Cirugía Torácica
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP