NCT02141165

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 19, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 15, 2017

Status Verified

January 1, 2017

Enrollment Period

2.1 years

First QC Date

February 17, 2014

Last Update Submit

March 14, 2017

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

sleep apneaportable monitorprimary carecost-effectivenessOSAS

Outcome Measures

Primary Outcomes (1)

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

    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.

    Before and after 6 months of follow-up

Study Arms (2)

Primary.

EXPERIMENTAL

Diagnosis, autoCPAP, follow up.

Device: Diagnosis, autoCPAP, follow up.

Hospital

ACTIVE COMPARATOR

Diagnosis, autoCPAP, follow up

Device: Diagnosis, autoCPAP, follow up.

Interventions

Diagnosis, autoCPAP, follow up.DEVICE

comparison between the efficacy of two protocol

HospitalPrimary.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juan Fernando Masa Jiménez

Cáceres, Cáceres, 10005, Spain

Location

Related Publications (1)

  • 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.

    PMID: 29664672DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea Syndromes

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Juan F. Masa, MD

    Hospital San Pedro de Alcántara. Cáceres. Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 17, 2014

First Posted

May 19, 2014

Study Start

March 1, 2014

Primary Completion

April 1, 2016

Study Completion

March 1, 2017

Last Updated

March 15, 2017

Record last verified: 2017-01

Locations

ES(1)