Home Nasal Pressure for Sleep Apnea Management in Primary Case (Primary)

March 14, 2017 updated by: Juan F. Masa, Sociedad Española de Neumología y Cirugía Torácica

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Cáceres, Spain, 10005
        • Juan Fernando Masa Jiménez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Snoring or apneas objectively observed during sleep by a partner;
  2. 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;
  3. Age between 18 and 70 years;
  4. Absence of any clinical suspicion of any other sleep pathology susceptible to coinciding with daytime sleepiness.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Primary.
Diagnosis, autoCPAP, follow up.
Device: Diagnosis, autoCPAP, follow up.
comparison between the efficacy of two protocol
Active Comparator: Hospital
Diagnosis, autoCPAP, follow up
Device: Diagnosis, autoCPAP, follow up.
comparison between the efficacy of two protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Before and after 6 months of follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Before and after 6 months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sociedad Española de Neumología y Cirugía Torácica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

February 17, 2014

First Submitted That Met QC Criteria

May 16, 2014

First Posted (Estimate)

May 19, 2014

Study Record Updates

Last Update Posted (Actual)

March 15, 2017

Last Update Submitted That Met QC Criteria

March 14, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI13/0238

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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