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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Sociedad Española de Neumología y Cirugía Torácica
Sponsor:
Information provided by (Responsible Party):
Juan F. Masa, Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier:
NCT00614952
First received: February 1, 2008
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

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 Intervention
Suspected Sleep Apnea
Daytime Sleepiness
Device: PSG (polysomnography)
Other: PR (respiratory polygraphy)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Diagnostic Validity Study and Cost Analysis of Domiciliary Respiratory

Resource links provided by NLM:


Further study details as provided by Sociedad Española de Neumología y Cirugía Torácica:

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. [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Direct and indirect cost of patients included in the study. [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
  • Relationship cost/efficacy [ Time Frame: at the end of study ] [ Designated as safety issue: No ]
  • Number of non valid studies in each group [ Time Frame: at the end of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: January 2006
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PR Other: PR (respiratory polygraphy)
respiratory polygraphy: level III of AASM
Active Comparator: PSG Device: PSG (polysomnography)
POLYSOMNOGRAPHY

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614952

Contacts
Contact: Juan F. Masa, MD 34-927-256289 fmasa@separ.es

Locations
Spain
Hospital San Pedro de Alcántara. Servicio Extremeño de Salud Recruiting
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

No publications provided

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
Study First Received: February 1, 2008
Last Updated: December 12, 2012
Health Authority: Spain: Ministry of Health and Consumption

ClinicalTrials.gov processed this record on October 20, 2014