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Completed

NCT Number: NCT02591979

PASHOS Project: Advanced Platform for Sleep Apnea Syndrome Assessment

The purpose of this study is to develop and validate a work-model in Primary Health Care for identifying patients with Sleep Apnea Syndrome, based on clinical variables and an ambulatory monitoring study.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients between 18 to 75 years.

Exclusion criteria

  • Cognitive impairment or psycho-physical deterioration that impede to perform ambulatory monitoring study.
  • Worsened or unstable cardiovascular or cerebrovascular disease.
  • Chronic insomnia (<5h sleep / day).
  • Relevant respiratory comorbidity that could interfere with arterial saturation measurements, as moderate to severe chronic obstructive pulmonary disease.
  • Neuromuscular disease.
  • Refusal to participate in the study.

Treatment and study plan

Primary outcomes

  1. Apnea/Hypopnea Index

    Time frame: At baseline

    At primary healthcare

  2. Apnea/Hypopnea Index

    Time frame: At 3 months

    At Sleep Lab Unit

Secondary outcomes

  1. Cardiovascular risk factors

    Time frame: At baseline

  2. History of cardiovascular or cerebrovascular disease

    Time frame: At baseline

  3. Lung function tests

    Time frame: At baseline

  4. Self-perceived sleepiness. Epworth Test

    Time frame: At baseline

    At primary healthcare

  5. Self-perceived sleepiness. Epworth Test

    Time frame: At 3 months

    At Sleep lab unit

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Registry information

Official study title

PASHOS Project: Advanced Platform for Sleep Apnea Syndrome Assessment. A Multi-Centre Study to Validate a Sleep Apnea Screening Model in Primary Health Care

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 30, 2015
Registry last updated
Mar 5, 2019

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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