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

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

Study Overview

• Status: Completed
• Conditions: Sleep Apnea Syndrome
• Intervention / Treatment: Procedure: diagnosis and therapeutic decision; Procedure: diagnosis and therapeutic decision

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 Type: Interventional
• Enrollment (Actual): 440
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Cáceres, Spain, 10005
    • Juan F. Masa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
Experimental: Home diagnosis; diagnosis of Sleep Apnea and therapeutic decision will be perform according to home respiratory polygraphy	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Sociedad Española de Neumología y Cirugía Torácica

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 17, 2012
• First Submitted That Met QC Criteria: December 18, 2012
• First Posted (Estimate): December 19, 2012

Study Record Updates

• Last Update Posted (Estimate): February 8, 2017
• Last Update Submitted That Met QC Criteria: February 6, 2017
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Sleep apnea, Portable monitor,autoCPAP
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Syndrome; Apnea
• Other Study ID Numbers: PI12/01240