Cost-effectiveness of Home Respiratory Polygraphy

Phase 3

Completed

• Conditions: Sleep Apnea Syndrome
• Interventions: Procedure: diagnosis and therapeutic decision

• Registration Number: NCT01752556
• Lead Sponsor: Sociedad Española de Neumología y Cirugía Torácica

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. 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

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-17
• Study First Submitted QC: 2012-12-18
• Study First Posted: 2012-12-19
• Primary Completion: 2015-06
• Status Verified: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hospital diagnosis	diagnosis and therapeutic decision	diagnosis of Sleep Apnea and therapeutic decision will perform according to polysomnography
Home diagnosis	diagnosis and therapeutic decision	diagnosis of Sleep Apnea and therapeutic decision will be perform according to home respiratory polygraphy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
the cost-effectiveness of diagnosis and therapeutic decision valued using the Epworth Scale and EuroQol 5D.	Six months

Trial Locations

Locations (1)

Juan F. Masa; 🇪🇸 Cáceres, Spain