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

Sociedad Española de Neumología y Cirugía Torácica

Status and phase: Completed; Phase 3

Conditions: Sleep Apnea Syndrome

Treatments: Procedure: diagnosis and therapeutic decision

Study type: Interventional

Funder types: Other

Identifiers

NCT01752556

PI12/01240

Details and patient eligibility

About

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

Full 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

Enrollment: 440 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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440 participants in 2 patient groups

Hospital diagnosis

Active Comparator group

Description:

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

Treatment:

Procedure: diagnosis and therapeutic decision

Procedure: diagnosis and therapeutic decision

Home diagnosis

Experimental group

Description:

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

Treatment:

Procedure: diagnosis and therapeutic decision

Procedure: diagnosis and therapeutic decision