Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
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

May 17, 2012
December 21, 2012
May 2012
December 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01752556 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Cost-effectiveness of Home Respiratory Polygraphy
Non-inferiority Randomized Control Trial About Efficacy and Cost-effectiveness of Home Respiratory Polygraphy Management in Sleep Apneas/Hypopneas Syndrome

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

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Sleep Apnea Syndrome
  • 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
  • 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
  • Active Comparator: Hospital diagnosis
    diagnosis of Sleep Apnea and therapeutic decision will perform according to polysomnography
    Intervention: Procedure: diagnosis and therapeutic decision
  • Experimental: Home diagnosis
    diagnosis of Sleep Apnea and therapeutic decision will be perform according to home respiratory polygraphy
    Intervention: Procedure: diagnosis and therapeutic decision
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
440
December 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Juan F. Masa, MD 34-927-927256289
Spain
 
NCT01752556
PI12/01240
No
Juan F. Masa, Sociedad Española de Neumología y Cirugía Torácica
Sociedad Española de Neumología y Cirugía Torácica
Not Provided
Principal Investigator: Juan F. Masa, MD Hospital San Pedro de Alcántara. Cáceres. Spain
Sociedad Española de Neumología y Cirugía Torácica
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP