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Completed

NCT Number: NCT02016339

Intensive Versus Standard Follow up to Improve Continuous Positive Airway Pressure (CPAP) Compliance

The purpose of this study was to compare the effects on sleepiness, quality of life, depression, hospitalization and deaths rate, of intensive vs standard interventions, on CPAP adherence, 2 years after CPAP initiation.

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Key information

Conditions

Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

There is limited data concerning long-term randomized clinical trials proving the long-term efficacy of intensive use, follow programs on improving CPAP use. Therefore the investigators aimed to compare the effects on sleepiness, quality of life, depression, hospitalization and deaths rate, of intensive vs standard interventions, on CPAP adherence, 2 years after CPAP initiation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • newly diagnosed obstructive sleep apnea syndrome by polysomnography according to standard criteria,
  • with moderate to severe sleep apnea,
  • no history of previously CPAP therapy and
  • with an above-elementary school education.

Exclusion criteria

  • refusal to participate,
  • refusal to CPAP therapy,
  • previous CPAP treatment,
  • central sleep apnoea syndrome,
  • Cheyne-stokes breathing pattern,
  • obesity hypoventilation syndrome,
  • restrictive ventilator syndromes,
  • congestive heart failure,
  • history of life-threatening arrhythmias,
  • cardiomyopathy,
  • long term oxygen therapy,
  • family or personal history of mental illness,
  • with drug or alcohol abuse,
  • severe cognitive impairment,
  • concurrent oncologic diseases and
  • history of narcolepsy.

Treatment and study plan

Standard Care

Behavioral

24-h consultation telephone line to the sleep nurses to answer questions regarding CPAP usage. Patients were reviewed at 1 month and at 3 month intervals during the first year and every 6 months thereafter in the CPAP clinic by the nurse. Additional visits or phone calls by sleep specialist if doubts about a patient's compliance or willingness to continue with the therapy.

Intensive care

Behavioral

Standard group care plus: Involvement of the patient's partner or family necessary. Extra education on sleep apnea and CPAP by sleep specialists via a 15-min videotape. 10- to 15-min lecture from the sleep clinic's nurses after CPAP titration study. Phone calls by nurses at 2 and 7 days. Early review of patients by sleep specialists at 15 and 30 days. Home visits by sleep nurses, if there doubts about a patients adherence

Primary outcomes

  1. Effect of intensive intervention on CPAP adherence

    Time frame: 24 months

Secondary outcomes

  1. Effect of intensive intervention on sleepiness.

    Time frame: 24 months

  2. Effect of intensive intervention on mood.

    Time frame: 24 months

  3. Effect of intensive intervention on quality of life

    Time frame: 24 months

Other outcomes

  1. Effect of intensive intervention on hospitalization rate.

    Time frame: 24 months

  2. Effect of intensive intervention on withdrawal of CPAP

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

University of Crete

Other

Registry information

Official study title

Intensive Versus Standard Follow up to Improve Continuous Positive Airway Pressure Compliance: The Greek Experience

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Dec 20, 2013
Registry last updated
Dec 23, 2013

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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