Cost/Effectiveness Analysis of the Respiratory Poligraphy at Home

NCT00614952 | Completed

• 1 other identifier: PI 050444
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

PR

EXPERIMENTAL

Other: PR (respiratory polygraphy)

PSG

ACTIVE COMPARATOR

Device: PSG (polysomnography)

Interventions

PSG (polysomnography) DEVICE

POLYSOMNOGRAPHY

PSG

PR (respiratory polygraphy) OTHER

respiratory polygraphy: level III of AASM

PR

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Psychophysical incapacity to answer questionnaires.
• Patients who do not get pass the proof of placing the PR (see below).
• 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)
• Structural cardiopaty or coronary documented non controlled by means of medical treatment .
• Toxicomanies. Alcoholism (more than 80 gr/day in men and 60 gr/day in women.
• Informed consent not obtained.

Sponsors & Collaborators

• Sociedad Española de Neumología y Cirugía Torácica: lead

Study Sites (1)

Hospital San Pedro de Alcántara. Servicio Extremeño de Salud

Cáceres, Caceres, 10003, Spain

Location

MeSH Terms

Conditions

Disorders of Excessive Somnolence

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Juan F. Masa, MD

  Hospital San Pedro de Alcántara. Cáceres. Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 1, 2008
• First Posted: February 14, 2008
• Study Start: January 1, 2006
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: April 20, 2016

Record last verified: 2012-12

Locations

ES (1)