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

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Diagnosis, autoCPAP, follow up.
Sponsored by
Sociedad Española de Neumología y Cirugía Torácica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome focused on measuring sleep apnea, portable monitor, primary care, cost-effectiveness, OSAS

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Juan Fernando Masa Jiménez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Primary.

Hospital

Arm Description

Diagnosis, autoCPAP, follow up.

Diagnosis, autoCPAP, follow up

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 17, 2014
Last Updated
March 14, 2017
Sponsor
Sociedad Española de Neumología y Cirugía Torácica
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1. Study Identification

Unique Protocol Identification Number
NCT02141165
Brief Title
Home Nasal Pressure for Sleep Apnea Management in Primary Case
Acronym
Primary
Official Title
Efficacy and Cost-Effectiveness of a Super Simplified System for the Management of Patients With Sleep Apneas in Primary Healthcare.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sociedad Española de Neumología y Cirugía Torácica

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
Keywords
sleep apnea, portable monitor, primary care, cost-effectiveness, OSAS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primary.
Arm Type
Experimental
Arm Description
Diagnosis, autoCPAP, follow up.
Arm Title
Hospital
Arm Type
Active Comparator
Arm Description
Diagnosis, autoCPAP, follow up
Intervention Type
Device
Intervention Name(s)
Diagnosis, autoCPAP, follow up.
Intervention Description
comparison between the efficacy of two protocol
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan F. Masa, MD
Organizational Affiliation
Hospital San Pedro de Alcántara. Cáceres. Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juan Fernando Masa Jiménez
City
Cáceres
ZIP/Postal Code
10005
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
29664672
Citation
Sanchez-Quiroga MA, Corral J, Gomez-de-Terreros FJ, Carmona-Bernal C, Asensio-Cruz MI, Cabello M, Martinez-Martinez MA, Egea CJ, Ordax E, Barbe F, Barca J, Masa JF; Spanish Sleep Network and Primary Care Group. Primary Care Physicians Can Comprehensively Manage Patients with Sleep Apnea. A Noninferiority Randomized Controlled Trial. Am J Respir Crit Care Med. 2018 Sep 1;198(5):648-656. doi: 10.1164/rccm.201710-2061OC.
Results Reference
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Home Nasal Pressure for Sleep Apnea Management in Primary Case

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