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

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ClinicalTrials.gov Identifier: NCT00614952
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Suspected Sleep Apnea Daytime Sleepiness Device: PSG (polysomnography) Other: PR (respiratory polygraphy)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic Validity Study and Cost Analysis of Domiciliary Respiratory
Study Start Date : January 2006
Primary Completion Date : December 2015
Study Completion Date : January 2016
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  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. [ Time Frame: at the end of the study ]

Secondary Outcome Measures :
  1. Direct and indirect cost of patients included in the study. [ Time Frame: at the end of the study ]
  2. Relationship cost/efficacy [ Time Frame: at the end of study ]
  3. Number of non valid studies in each group [ Time Frame: at the end of study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00614952


Locations
Spain
Hospital San Pedro de Alcántara. Servicio Extremeño de Salud
Caceres, Spain, 10003
Sponsors and Collaborators
Sociedad Española de Neumología y Cirugía Torácica
Investigators
Principal Investigator: Juan F. Masa, MD Hospital San Pedro de Alcántara. Cáceres. Spain
More Information

Responsible Party: Juan F. Masa, MD, Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier: NCT00614952     History of Changes
Other Study ID Numbers: PI 050444
First Posted: February 14, 2008    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: December 2012