Cost/Effectiveness Analysis of the Respiratory Poligraphy at Home

NCT ID: NCT00614952

Last Updated: 2016-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2016-01-31

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.

Conditions

Suspected Sleep Apnea; Daytime Sleepiness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PR

Group Type: EXPERIMENTAL

PR (respiratory polygraphy)

Intervention Type: OTHER

respiratory polygraphy: level III of AASM

PSG

Group Type: ACTIVE_COMPARATOR

PSG (polysomnography)

Intervention Type: DEVICE

POLYSOMNOGRAPHY

Interventions

PSG (polysomnography)

POLYSOMNOGRAPHY

Intervention Type: DEVICE

PR (respiratory polygraphy)

respiratory polygraphy: level III of AASM

Intervention Type: OTHER

Eligibility Criteria

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.

• 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

Hospital San Pedro de Alcántara. Servicio Extremeño de Salud

Cáceres, Caceres, Spain

Countries

Spain

Other Identifiers

PI 050444

Identifier Type: -

Identifier Source: org_study_id