Cost-effectiveness of Home Respiratory Polygraphy (HRP-M)
This study is currently recruiting participants.
Verified December 2012 by Sociedad Española de Neumología y Cirugía Torácica
Sponsor:
Sociedad Española de Neumología y Cirugía Torácica
Information provided by (Responsible Party):
Juan F. Masa, Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier:
NCT01752556
First received: May 17, 2012
Last updated: December 21, 2012
Last verified: December 2012
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Purpose
Primary objectives:
The efficacy of the therapeutic decision taken by respiratory polygraphy (RP) against polysomnography (PSG) using the Epworth scale;
Secondary Objective:
- the cost-effectiveness of diagnosis and therapeutic decision valued using the Epworth Scale and EuroQol 5D.
- 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
| Condition | Intervention | Phase |
|---|---|---|
|
Sleep Apnea Syndrome |
Procedure: diagnosis and therapeutic decision |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Non-inferiority Randomized Control Trial About Efficacy and Cost-effectiveness of Home Respiratory Polygraphy Management in Sleep Apneas/Hypopneas Syndrome |
Resource links provided by NLM:
Further study details as provided by Sociedad Española de Neumología y Cirugía Torácica:
Primary Outcome Measures:
- 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. [ Time Frame: Six months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- the cost-effectiveness of diagnosis and therapeutic decision valued using the Epworth Scale and EuroQol 5D. [ Time Frame: Six months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 440 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
|
Experimental: Home diagnosis
diagnosis of Sleep Apnea and therapeutic decision will be perform according to home respiratory polygraphy
|
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
|
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
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Snoring or sleep apneas observed by partner
- Symptoms that may be secondary to the apneas/hypopneas - concretely, an ESS ≥10
- Age between 18 and 70
- Absence of clinical suspicion of any other sleep pathology which could cause daytime sleepiness
Exclusion criteria:
- Psycho-physical inability to complete questionnaires
- documented structural or coronary cardiopathy not controlled by medical treatment
- Cheyennes-Stokes Syndrome
- Patient has undergone an uvulopalatopharyngoplasty
- Unable to provide informed consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752556
Contacts
| Contact: Juan F. Masa, MD | 34-927-927256289 |
Locations
| Spain | |
| Juan F. Masa | Recruiting |
| Cáceres, Spain, 10005 | |
| Contact: Juan F. Masa, MD 34-927-256289 fmasa@separ.es | |
Sponsors and Collaborators
Sociedad Española de Neumología y Cirugía Torácica
Investigators
| Principal Investigator: | Juan F. Masa, MD | Hospital San Pedro de Alcántara. Cáceres. Spain |
More Information
No publications provided
| Responsible Party: | Juan F. Masa, MD, Sociedad Española de Neumología y Cirugía Torácica |
| ClinicalTrials.gov Identifier: | NCT01752556 History of Changes |
| Other Study ID Numbers: | PI12/01240 |
| Study First Received: | May 17, 2012 |
| Last Updated: | December 21, 2012 |
| Health Authority: | Spain: Ministry of Health and Consumption |
Keywords provided by Sociedad Española de Neumología y Cirugía Torácica:
|
Sleep apnea, Portable monitor,autoCPAP |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013