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OpenTrials
Completed

NCT Number: NCT01918449

Follow-up of Patients With Obstructive Sleep Apnea in Primary Care.

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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Key information

Conditions

OSA

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital santa Maria

Lleida, Catalonia, 25198, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Clinical follow up by general practitioners in primary care

Other

The study evaluates two different setting to follow up patients with obstructive sleep apnea on CPAP treatment

Primary outcomes

  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 outcomes

  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 outcomes

  1. Body mass index

    Time frame: Six month

Sponsors and collaborators

Lead sponsor

Sociedad Española de Neumología y Cirugía Torácica

Other

Collaborators

  • Fundacio Catalana de Pneumologia
  • Instituto de Salud Carlos III

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Aug 7, 2013
Registry last updated
Nov 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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