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Completed

NCT Number: NCT02141165

Home Nasal Pressure for Sleep Apnea Management in Primary Case

Primary objectives: To determine the efficacy and cost-effectiveness of a management program for patients with obstructive sleep apnea syndrome (OSAS) carried out in primary or specialist healthcare. In the primary arm, the diagnosis and therapeutic decision will be made by means of a domiciliary nasal pressure (DNP) channel and oximetry while the specialist healthcare arm will use polysomnography (PSG) in a hospital. Patients with an intermediate-high suspicion of OSAS will be included, taking as primary variables the Epworth scale, for efficacy, and the Epworth scale and EuroQol 5D, for cost-effectiveness.

Secondary objectives: efficacy of the two SAHS management programs according to the following secondary variables: a) quality-of-life tests: FOSQ questionnaire, SF36 and analogical wellbeing scale, b) adherence to and compliance with the treatment.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Juan Fernando Masa Jiménez

Cáceres, 10005, Spain

About this study

Design: prospective, randomized, controlled, open, parallel, non-inferiority. A total of 280 patients will be randomized for management on the basis of DNP (primary) or PSG (specialist), thereby giving rise to 4 groups: two treated and two not treated with CPAP. The former will undergo a home auto-titration. The follow-up will last 6 months and include 4 evaluations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Snoring or apneas objectively observed during sleep by a partner;
  • Symptoms that are potentially secondary to apneas/hypopneas with an intermediate-high probability of being treated with CPAP. In operative terms, Epworth scale ≥12 or previous cardiovascular disease;
  • Age between 18 and 70 years;
  • Absence of any clinical suspicion of any other sleep pathology susceptible to coinciding with daytime sleepiness.

Exclusion criteria

  • Psycho-physical incapacity to complete questionnaires;
  • Documented structural or coronary heart disease uncontrolled by any medical treatment;
  • Cheyne-Stokes syndrome;
  • Patients subjected to uvulopalatopharyngoplasty;
  • Significant nasal obstruction impeding the use of CPAP;
  • Pregnancy;
  • Lack of informed consent.

Treatment and study plan

Diagnosis, autoCPAP, follow up.

Device

comparison between the efficacy of two protocol

Primary outcomes

  1. Efficacy of the extra- and intra-hospital programs using DNP or PSG, taking as primary variable the Epworth scale.

    Time frame: Before and after 6 months of follow-up

Secondary outcomes

  1. Cost-effectiveness of the exta- and intra-hospital management programs using DNP or PSG, evaluated by means of the Epworth scale and EuroQol 5D.

    Time frame: Before and after 6 months of follow-up

Sponsors and collaborators

Lead sponsor

Sociedad Española de Neumología y Cirugía Torácica

Other

Registry information

Official study title

Efficacy and Cost-Effectiveness of a Super Simplified System for the Management of Patients With Sleep Apneas in Primary Healthcare.

Acronym: Primary

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
May 19, 2014
Registry last updated
Mar 15, 2017

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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