Cost/Effectiveness Analysis of the Respiratory Poligraphy at Home (Telesleep)

Diagnostic Validity Study and Cost Analysis of Domiciliary Respiratory

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.

Study Overview

• Status: Completed
• Conditions: Suspected Sleep Apnea; Daytime Sleepiness
• Intervention / Treatment: Other: PR (respiratory polygraphy); Device: PSG (polysomnography)

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Caceres, Spain, 10003
    • Hospital San Pedro de Alcántara. Servicio Extremeño de Salud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PSG	Device: PSG (polysomnography); POLYSOMNOGRAPHY
Experimental: PR	Other: PR (respiratory polygraphy); respiratory polygraphy: level III of AASM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Sociedad Española de Neumología y Cirugía Torácica

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: February 1, 2008
• First Submitted That Met QC Criteria: February 13, 2008
• First Posted (Estimate): February 14, 2008

Study Record Updates

• Last Update Posted (Estimate): April 20, 2016
• Last Update Submitted That Met QC Criteria: April 19, 2016
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disorders of Excessive Somnolence; Sleepiness
• Other Study ID Numbers: PI 050444