NCT01752556

Brief Summary

Primary objectives: The efficacy of the therapeutic decision taken by respiratory polygraphy (RP) against polysomnography (PSG) using the Epworth scale; Secondary Objective:

  1. 1.the cost-effectiveness of diagnosis and therapeutic decision valued using the Epworth Scale and EuroQol 5D.
  2. 2.effectiveness of the therapeutic decision by means of: 1) quality of life tests, 2) adherence and compliance to treatment, 3) blood pressure MAP, 4) biochemistry determinations. Design: prospective, randomized, controlled, open, parallel of non-inferiority. 440 patients will be randomized to diagnose and follow treatment based on the RP or the PSG. The follow-up will last 6 months with 4 assessments. Statistical analysis: We will compare the change in the Epworth scale between both arms of treatment through analysis of covariance. The premise of non-inferiority is -2 at the lower limit of 95% IC. Secondary variables will be analyzed using differences in independent means (or non-parametric equivalent) or Chi2 for dichotomous variables. Cost-effectiveness: costs generated by one and another method will be evaluated against the effectiveness of the primary variable using Bayesian techniques

Trial Health

87
On Track

Trial Health Score

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

Enrollment
440

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2012

Longer than P75 for phase_3

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

Study Start

First participant enrolled

May 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2012

Completed
7 months until next milestone

First Posted

Study publicly available on registry

December 19, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 8, 2017

Status Verified

December 1, 2016

Enrollment Period

3.1 years

First QC Date

May 17, 2012

Last Update Submit

February 6, 2017

Conditions

Sleep Apnea Syndrome

Keywords

Sleep apnea, Portable monitor,autoCPAP

Outcome Measures

Primary Outcomes (1)

  • Determine the efficacy of diagnosis and therapeutic decision-making evaluated using Epworth sleepiness scale as primary variable in patients managed by home RP and by PSG after six months of follow-up.

    Six months

Secondary Outcomes (1)

  • the cost-effectiveness of diagnosis and therapeutic decision valued using the Epworth Scale and EuroQol 5D.

    Six months

Study Arms (2)

Hospital diagnosis

ACTIVE COMPARATOR

diagnosis of Sleep Apnea and therapeutic decision will perform according to polysomnography

Procedure: diagnosis and therapeutic decision

Home diagnosis

EXPERIMENTAL

diagnosis of Sleep Apnea and therapeutic decision will be perform according to home respiratory polygraphy

Procedure: diagnosis and therapeutic decision

Interventions

diagnosis and therapeutic decisionPROCEDURE

A conventional polysomnography will be done to perform the diagnosis and therapeutic decision(CPAP or not). Treated and untreated will be followed 6 moths

Hospital diagnosis

Eligibility Criteria

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

You may qualify if:

  • Snoring or sleep apneas observed by partner
  • Symptoms that may be secondary to the apneas/hypopneas - concretely, an ESS ≥10
  • Age between 18 and 70
  • Absence of clinical suspicion of any other sleep pathology which could cause daytime sleepiness

You may not qualify if:

  • Psycho-physical inability to complete questionnaires
  • documented structural or coronary cardiopathy not controlled by medical treatment
  • Cheyennes-Stokes Syndrome
  • Patient has undergone an uvulopalatopharyngoplasty
  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juan F. Masa

Cáceres, Cáceres, 10005, Spain

Location

Related Publications (1)

  • Corral J, Sanchez-Quiroga MA, Carmona-Bernal C, Sanchez-Armengol A, de la Torre AS, Duran-Cantolla J, Egea CJ, Salord N, Monasterio C, Teran J, Alonso-Alvarez ML, Munoz-Mendez J, Arias EM, Cabello M, Montserrat JM, De la Pena M, Serrano JC, Barbe F, Masa JF; Spanish Sleep Network. Conventional Polysomnography Is Not Necessary for the Management of Most Patients with Suspected Obstructive Sleep Apnea. Noninferiority, Randomized Controlled Trial. Am J Respir Crit Care Med. 2017 Nov 1;196(9):1181-1190. doi: 10.1164/rccm.201612-2497OC.

    PMID: 28636405DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes

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
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 17, 2012

First Posted

December 19, 2012

Study Start

May 1, 2012

Primary Completion

June 1, 2015

Study Completion

December 1, 2016

Last Updated

February 8, 2017

Record last verified: 2016-12

Locations

ES(1)