Cost/Effectiveness Analysis of the Respiratory Poligraphy at Home

Not Applicable

Completed

• Conditions: Daytime Sleepiness; Suspected Sleep Apnea
• Interventions: Device: PSG (polysomnography); Other: PR (respiratory polygraphy)

• Registration Number: NCT00614952
• Lead Sponsor: Sociedad Española de Neumología y Cirugía Torácica

Brief Summary

The abbreviated diagnostic sleep studies (RP), made at home and transferred telematically to the sleep laboratory, are useful for the diagnosis of sleep apnea and due to a lower cost, it could be an alternative to conventional polysomnography. Objectives: 1) Usefulness of domiciliary study evaluated by percentage of patients diagnosed of SAHS compared with PSG and agreement in the therapeutic decision. 2) Direct costs of patients included in the study. Design: controlled, randomized, crossed and blind (320 patients) comparing PR made at home with PSG, in patients suspicious of SAHS. The equipment transfer will be made by a transport agency from home to home in order to be universal the access to this diagnostic model. The file transmission with the raw data of the study will be made telematically by GPRS. If the aims of the study reach an end there will be a considerable change in the clinical practice making possible the international acceptation of domiciliary PR as diagnosis of SAHS and adapting the diagnosis of this syndrome to the new technologies of communication. The universalization of domiciliary PR would make possible that the diagnosis of SAHS could be done in any patient and in any country with GPRS technology and a transport agency, that is to say in all developed countries. As sleep apneas affect 5-7 million persons in Spain and there is association between sleep apneas and cardiovascular risk, in the immediate future we must evaluate this disease as we do today with the cholesterol determination. If our results are as predicted, the primary care physician could start and in a lot of cases finish the SAHS diagnostic process. This would simplify remarkably the diagnosis of SAHS and would alleviate a lot the process cost all over the world.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2008-02-01
• Study First Submitted QC: 2008-02-13
• Study First Posted: 2008-02-14
• Status Verified: 2012-12
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Last Update Submitted: 2016-04-19
• Last Update Posted: 2016-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

1. Age between 18 and 70 years.
2. Without clinical suspicion referred to any other sleep pathology susceptible of presenting daytime sleepiness.
3. Living 20 Km or more far from the hospital participating in the study.

Exclusion Criteria

1. Psychophysical incapacity to answer questionnaires.
2. Patients who do not get pass the proof of placing the PR (see below).
3. Patients who present restrictive chronic disease previously diagnosed (neoplasy, any origin chronic pain, renal failure, severe chronic obstructive pulmonary disease and any other limited chronic disease)
4. Structural cardiopaty or coronary documented non controlled by means of medical treatment .
5. Toxicomanies. Alcoholism (more than 80 gr/day in men and 60 gr/day in women.
6. Informed consent not obtained.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PSG	PSG (polysomnography)	-
PR	PR (respiratory polygraphy)	-

Primary Outcome Measures

Name	Time	Method
Effectiveness of the two diagnostic models (PR at home and PSG) evaluated by means of percentage of patients who have established the diagnosis of SAHS and agreement in the therapeutic decision.	at the end of the study

Secondary Outcome Measures

Name	Time	Method
Direct and indirect cost of patients included in the study.	at the end of the study
Relationship cost/efficacy	at the end of study
Number of non valid studies in each group	at the end of study

Trial Locations

Locations (1)

Hospital San Pedro de Alcántara. Servicio Extremeño de Salud; 🇪🇸 Caceres, Spain