NCT01752556

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 440 (actual)
• Sponsor: Sociedad Española de Neumología y Cirugía Torácica · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Sleep Apnea Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-06-01
• Completion: 2016-12-01
• First posted: 2012-12-19
• Last updated: 2017-02-08

Locations

1 site across 1 country: Spain