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Domiciliary Diagnosis and Follow up in Obstructive Apnoea Syndrome

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ClinicalTrials.gov Identifier: NCT01001858
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : July 27, 2010
Sponsor:
Information provided by:
Hospital Universitario San Juan de Alicante

Brief Summary:
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 or disease Intervention/treatment Phase
Obstructive Sleep Apnea Other: Diagnosis and monitoring of OSA patients Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Domiciliary Diagnosis and Follow up in Obstructive Apnoea Syndrome
Study Start Date : June 2003
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Differences in compliance among the three different strategies, measured by CPAP hours of use [ Time Frame: six months follow-up ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT01001858


Locations
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Spain
Hospital San Juan de Alicante
San Juan, Alicante, Spain, 03550
Sponsors and Collaborators
Hospital Universitario San Juan de Alicante
Investigators
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Study Director: Eusebi Chiner Vives, MD Jefe de Sección de Neumología del Hospital San Juan de Alicante. España
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ada Luz Andreu Rodríguez, HOspital San Juan de Alicante. España
ClinicalTrials.gov Identifier: NCT01001858    
Other Study ID Numbers: 7387
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: July 27, 2010
Last Verified: October 2009
Keywords provided by Hospital Universitario San Juan de Alicante:
OSA
CPAP compliance
nurse domiciliary led
sleep disease
Additional relevant MeSH terms:
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Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Apnea Syndromes
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases