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Domiciliary Diagnosis and Follow up in Obstructive Apnoea Syndrome

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Diagnosis and monitoring of OSA patients
Sponsored by
Hospital Universitario San Juan de Alicante
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obstructive Sleep Apnea focused on measuring OSA, CPAP compliance, nurse domiciliary led, sleep disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital San Juan de Alicante

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Domiciliary group

Hospital Group

Mixed Group

Arm Description

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.

In this group diagnosis was made by in-hospital PSG. Follow-up was performed at hospital by a specialist Physician

In this group diagnosis was made by home RP, and follow-up at hospital

Outcomes

Primary Outcome Measures

Differences in compliance among the three different strategies, measured by CPAP hours of use

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.

Full Information

First Posted
October 7, 2009
Last Updated
July 26, 2010
Sponsor
Hospital Universitario San Juan de Alicante
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1. Study Identification

Unique Protocol Identification Number
NCT01001858
Brief Title
Domiciliary Diagnosis and Follow up in Obstructive Apnoea Syndrome
Official Title
Domiciliary Diagnosis and Follow up in Obstructive Apnoea Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Universitario San Juan de Alicante

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The aim of our 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. Detailed Description: We conducted a prospective comparative study. Patients referred for suspected OSAS were evaluated. In the first visit patients completed four questionnaires: Epworth sleepiness scale, Impact Functional Illness Questionnaire (FOSQ), activity questionnaire and symptom questionnaire. Patients were randomised to three groups: Group A (domiciliary group): home based diagnosis by home respiratory polygraphy (RP) and home review conducted by a specialist nurse Group B (Hospital group): hospital based diagnosis by polysomnography (PSG) and clinical review conducted by a Pulmonologist Group C (mixed group): home based diagnosis by home respiratory polygraphy (RP) and clinical review conducted by a Pulmonologist Following the diagnostic test (PSG or RP), patients were visited by the Pulmonologist, who identified the need for CPAP treatment. Patients were evaluated after 1,3 and 6 months of CPAP treatment. In all follow-up visits compliance was evaluated by objective methods and questionnaires described above were filled in. In domiciliary group, phone calls or hospital appointments were made if low compliance was detected or if some problem with treatment was detected. Instrumentation. Conventional PSG was performed in hospital supervised by a trained nurse. PSG used for the study was Somnostar alfa®. Parameters obtained were: electroencephalogram (C3-A2, C4-A1), electrooculogram electromyogram, electrocardiogram (V2 modified), respiratory effort by thoracic and abdominal resistance bands, air flow with nasal cannula pressure connected to a transducer, oxygen saturation with a pulseoximeter, and snoring with a selective microphone. PSG was manually interpreted in 30 seconds epochs, according to Rechschaffen and Kales criteria.The apnea-hypopnea index (AHI) was defined as the number of apneas-hypopneas divided by the number of hours of sleep. OSA diagnosis was done if AHI was >10 /h. Respiratory polygraphy was performed in a non-attended way in patient's home. The nurse who monitorized the patient in the home setting, instructed the patient on the proper use of the RP. A validated respiratory polygraphy system corresponding to ASDA level III (Stardust®) was used. The parameters monitorized were: nasal flow, chest movement, oxyhemoglobin saturation, pulse and body position. The same cardio-respiratory variables that we identified in PSG, were registered. An event rate (number of apneas + number of hypopnea divided by the number of hours recorded)> 15 was considered as a diagnosis. The study were recorded by computer system and manually interpreted by a physician. In case of invalid registration we performed a second PR. If in doubt after the second study a PSG was performed. Follow-up visits and assessment of compliance: Hospital monitoring group: Effective compliance was calculated by mean of the CPAP hour meter, dividing the total number of hours timer by the number of days of use. We discounted 10% of the time, which is the average time of ineffective pressure. Patients were considered adherent if they use CPAP at least 4 hours during 70% of the week Follow-up visits by nurses: This group of patients was treated at home through a system of fixed pressure CPAP (REMstar Pro, Respironics ®), with a memory card which can store information about the number of hours of effective pressure. It also allows to know the number of days of CPAP use. In all visits the nurse collect the memory card for later analysis, which was performed by a physician.The nurse responsible for the program evaluated the need of reinforcing in order to get an optimal compliance. If it was considered necessary, the patient was evaluated by the Pulmonologist either by mean of a phone call or of an hospital appointment. All patients in this group were contacted by phone at least once during the first month of CPAP treatment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
OSA, CPAP compliance, nurse domiciliary led, sleep disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Domiciliary group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Hospital Group
Arm Type
Active Comparator
Arm Description
In this group diagnosis was made by in-hospital PSG. Follow-up was performed at hospital by a specialist Physician
Arm Title
Mixed Group
Arm Type
Active Comparator
Arm Description
In this group diagnosis was made by home RP, and follow-up at hospital
Intervention Type
Other
Intervention Name(s)
Diagnosis and monitoring of OSA patients
Other Intervention Name(s)
Domiciliary group: group A, Hospital group: group B, Mixed Group: groupC
Intervention Description
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)
Primary Outcome Measure Information:
Title
Differences in compliance among the three different strategies, measured by CPAP hours of use
Time Frame
six months follow-up
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eusebi Chiner Vives, MD
Organizational Affiliation
Jefe de Sección de Neumología del Hospital San Juan de Alicante. España
Official's Role
Study Director
Facility Information:
Facility Name
Hospital San Juan de Alicante
City
San Juan
State/Province
Alicante
ZIP/Postal Code
03550
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
21719490
Citation
Andreu AL, Chiner E, Sancho-Chust JN, Pastor E, Llombart M, Gomez-Merino E, Senent C, Barbe F. Effect of an ambulatory diagnostic and treatment programme in patients with sleep apnoea. Eur Respir J. 2012 Feb;39(2):305-12. doi: 10.1183/09031936.00013311. Epub 2011 Jun 30.
Results Reference
derived

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Domiciliary Diagnosis and Follow up in Obstructive Apnoea Syndrome

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