Cost-effectiveness of Home Respiratory Polygraphy

NCT ID: NCT01752556

Last Updated: 2017-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 440 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2016-12-31

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

Conditions

Sleep Apnea Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hospital diagnosis

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

Group Type: ACTIVE_COMPARATOR

diagnosis and therapeutic decision

Intervention Type: PROCEDURE

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

Home diagnosis

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

Group Type: EXPERIMENTAL

diagnosis and therapeutic decision

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sociedad Española de Neumología y Cirugía Torácica

OTHER

Sponsor Role: lead

Responsible Party

Juan F. Masa

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan F. Masa, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital San Pedro de Alcántara. Cáceres. Spain

Locations

Juan F. Masa

Cáceres, Cáceres, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 28636405 (View on PubMed)

Other Identifiers

PI12/01240

Identifier Type: -

Identifier Source: org_study_id