Cost/Effectiveness Analysis of the Respiratory Poligraphy at Home

Daytime Sleepiness Clinical Trial

— Telesleep  

Official title:

Diagnostic Validity Study and Cost Analysis of Domiciliary Respiratory

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614952
• Other study ID #: PI 050444
• Status: Completed
• Phase: N/A
• First received: February 1, 2008
• Last updated: April 19, 2016
• Start date: January 2006
• Est. completion date: January 2016

Study information

• Verified date: December 2012
• Source: Sociedad Española de Neumología y Cirugía Torácica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Daytime Sleepiness
• Suspected Sleep Apnea

Intervention

Device:
• PSG (polysomnography)
POLYSOMNOGRAPHY

Other:
• PR (respiratory polygraphy)
respiratory polygraphy: level III of AASM

Locations

Country	Name	City	State
Spain	Hospital San Pedro de Alcántara. Servicio Extremeño de Salud	Caceres

Sponsors (1)

Lead Sponsor	Collaborator
Sociedad Española de Neumología y Cirugía Torácica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Direct and indirect cost of patients included in the study.		at the end of the study	No
Secondary	Relationship cost/efficacy		at the end of study	No
Secondary	Number of non valid studies in each group		at the end of study	No