Cost-effectiveness of Home Respiratory Polygraphy (HRP-M)

This study is currently recruiting participants.
Verified December 2012 by Sociedad Española de Neumología y Cirugía Torácica
Sponsor:
Information provided by (Responsible Party):
Juan F. Masa, Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier:
NCT01752556
First received: May 17, 2012
Last updated: December 21, 2012
Last verified: December 2012
  Purpose

Primary objectives:

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

Secondary Objective:

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

Condition Intervention Phase
Sleep Apnea Syndrome
Procedure: diagnosis and therapeutic decision
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Non-inferiority Randomized Control Trial About Efficacy and Cost-effectiveness of Home Respiratory Polygraphy Management in Sleep Apneas/Hypopneas Syndrome

Resource links provided by NLM:


Further study details as provided by Sociedad Española de Neumología y Cirugía Torácica:

Primary Outcome Measures:
  • 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. [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the cost-effectiveness of diagnosis and therapeutic decision valued using the Epworth Scale and EuroQol 5D. [ Time Frame: Six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 440
Study Start Date: May 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hospital diagnosis
diagnosis of Sleep Apnea and therapeutic decision will perform according to polysomnography
Procedure: diagnosis and therapeutic decision
A conventional polysomnography will be done to perform the diagnosis and therapeutic decision(CPAP or not). Treated and untreated will be followed 6 moths
Experimental: Home diagnosis
diagnosis of Sleep Apnea and therapeutic decision will be perform according to home respiratory polygraphy
Procedure: diagnosis and therapeutic decision
A home respiratory polygraphy will be done to perform the diagnosis and therapeutic decision(CPAP or not). Treated and untreated will be followed 6 months

Detailed Description:

Design: Prospective, randomized, controlled, open, parallel noninferiority. 440 patients will be randomized to diagnose and follow treatment based on the PR or PSG generating four groups: two treated and two untreated with CPAP. The latter did not undergo self-certification home. The monitoring will be 6 months and 4 assessments. Statistical analysis: compare the change of the scale Epworth before and after the intervention between both treatment arms using analysis of covariance. The premise is non-inferiority of -1.6 at the lower limit of 95%. Secondary variables were analyzed by independent means differences (or nonparametric equivalent) or Chi2 for dichotomous variables. Cost-effectiveness: the costs generated by the two methods will be measured against the effectiveness of the primary endpoint using Bayesian techniques

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

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

Exclusion criteria:

  1. Psycho-physical inability to complete questionnaires
  2. documented structural or coronary cardiopathy not controlled by medical treatment
  3. Cheyennes-Stokes Syndrome
  4. Patient has undergone an uvulopalatopharyngoplasty
  5. Unable to provide informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752556

Contacts
Contact: Juan F. Masa, MD 34-927-927256289

Locations
Spain
Juan F. Masa Recruiting
Cáceres, Spain, 10005
Contact: Juan F. Masa, MD    34-927-256289    fmasa@separ.es   
Sponsors and Collaborators
Sociedad Española de Neumología y Cirugía Torácica
Investigators
Principal Investigator: Juan F. Masa, MD Hospital San Pedro de Alcántara. Cáceres. Spain
  More Information

No publications provided

Responsible Party: Juan F. Masa, MD, Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier: NCT01752556     History of Changes
Other Study ID Numbers: PI12/01240
Study First Received: May 17, 2012
Last Updated: December 21, 2012
Health Authority: Spain: Ministry of Health and Consumption

Keywords provided by Sociedad Española de Neumología y Cirugía Torácica:
Sleep apnea, Portable monitor,autoCPAP

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 14, 2014