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

Primary Purpose

Suspected Sleep Apnea, Daytime Sleepiness

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PSG (polysomnography)
PR (respiratory polygraphy)
Sponsored by
Sociedad Española de Neumología y Cirugía Torácica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Suspected Sleep Apnea

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital San Pedro de Alcántara. Servicio Extremeño de Salud

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PR

PSG

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 1, 2008
Last Updated
April 19, 2016
Sponsor
Sociedad Española de Neumología y Cirugía Torácica
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1. Study Identification

Unique Protocol Identification Number
NCT00614952
Brief Title
Cost/Effectiveness Analysis of the Respiratory Poligraphy at Home
Acronym
Telesleep
Official Title
Diagnostic Validity Study and Cost Analysis of Domiciliary Respiratory
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sociedad Española de Neumología y Cirugía Torácica

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suspected Sleep Apnea, Daytime Sleepiness

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PR
Arm Type
Experimental
Arm Title
PSG
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
PSG (polysomnography)
Intervention Description
POLYSOMNOGRAPHY
Intervention Type
Other
Intervention Name(s)
PR (respiratory polygraphy)
Intervention Description
respiratory polygraphy: level III of AASM
Primary Outcome Measure Information:
Title
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.
Time Frame
at the end of the study
Secondary Outcome Measure Information:
Title
Direct and indirect cost of patients included in the study.
Time Frame
at the end of the study
Title
Relationship cost/efficacy
Time Frame
at the end of study
Title
Number of non valid studies in each group
Time Frame
at the end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan F. Masa, MD
Organizational Affiliation
Hospital San Pedro de Alcántara. Cáceres. Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital San Pedro de Alcántara. Servicio Extremeño de Salud
City
Caceres
ZIP/Postal Code
10003
Country
Spain

12. IPD Sharing Statement

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Cost/Effectiveness Analysis of the Respiratory Poligraphy at Home

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