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Domiciliary Diagnosis and Follow up in Obstructive Apnoea Syndrome

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitario San Juan de Alicante
ClinicalTrials.gov Identifier:
NCT01001858
First received: October 7, 2009
Last updated: July 26, 2010
Last verified: October 2009
History of Changes
  Purpose

The aim of the investigators study was to evaluate the effectiveness of a home programme (diagnosis and follow-up) in patients with Obstructive Sleep Apnea (OSA) syndrome treated with CPAP and to analyze the cost of this approach.


Condition Intervention
Obstructive Sleep Apnea
 Other: Diagnosis and monitoring of OSA patients

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Domiciliary Diagnosis and Follow up in Obstructive Apnoea Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by Hospital Universitario San Juan de Alicante:

Primary Outcome Measures:
  • Differences in compliance among the three different strategies, measured by CPAP hours of use [ Time Frame: six months follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • costs of the three different strategies, including number of visits and phone calls that were necessary to improve compliance and additional diagnostic tests. [ Time Frame: six months follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 66
Study Start Date: June 2003
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Domiciliary group
In this group OSA diagnosis was performed at patient's home by mean of non-attended RP. All follow-up visits were conducted by a trained nurse in patient's home.
 Other: Diagnosis and monitoring of OSA patients
The difference between the three strategies is given by the method used for OSA diagnosis (domiciliary RP or hospital PSG) and the type of monitoring carried out after initiating CPAP treatment (by physician at hospital or by a trained nurse in patient's home)
Other Names:
  • Domiciliary group: group A
  • Hospital group: group B
  • Mixed Group: groupC
Active Comparator: Hospital Group
In this group diagnosis was made by in-hospital PSG. Follow-up was performed at hospital by a specialist Physician
 Other: Diagnosis and monitoring of OSA patients
The difference between the three strategies is given by the method used for OSA diagnosis (domiciliary RP or hospital PSG) and the type of monitoring carried out after initiating CPAP treatment (by physician at hospital or by a trained nurse in patient's home)
Other Names:
  • Domiciliary group: group A
  • Hospital group: group B
  • Mixed Group: groupC
Active Comparator: Mixed Group
In this group diagnosis was made by home RP, and follow-up at hospital
 Other: Diagnosis and monitoring of OSA patients
The difference between the three strategies is given by the method used for OSA diagnosis (domiciliary RP or hospital PSG) and the type of monitoring carried out after initiating CPAP treatment (by physician at hospital or by a trained nurse in patient's home)
Other Names:
  • Domiciliary group: group A
  • Hospital group: group B
  • Mixed Group: groupC

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Patients with high probability of OSA, defined by two or more of :

  • daytime sleepiness
  • snoring
  • recognized apnoeic episodes
  • associating obesity and / or hypertension

Exclusion Criteria:

  • Patients with impaired lung function ( overlap syndrome, obesity-hypoventilation syndrome, restrictive disorders), associated pathology (psychiatric disorder, periodic limb movements, dyssomnias or other parasomnias)
  • Patients treated with CPAP
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001858

Locations
Spain
Hospital San Juan de Alicante
San Juan, Alicante, Spain, 03550
Sponsors and Collaborators
Hospital Universitario San Juan de Alicante
Investigators
Study Director: Eusebi Chiner Vives, MD Jefe de Sección de Neumología del Hospital San Juan de Alicante. España
  More Information

No publications provided by Hospital Universitario San Juan de Alicante

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ada Luz Andreu Rodríguez, HOspital San Juan de Alicante. España
ClinicalTrials.gov Identifier: NCT01001858     History of Changes
Other Study ID Numbers: 7387
Study First Received: October 7, 2009
Last Updated: July 26, 2010
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital Universitario San Juan de Alicante:
OSA
CPAP compliance
nurse domiciliary led
sleep disease

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013