Domiciliary Diagnosis and Follow up in Obstructive Apnoea Syndrome

July 26, 2010 updated by: Hospital Universitario San Juan de Alicante
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alicante
      • San Juan, Alicante, Spain, 03550
        • Hospital San Juan de Alicante

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differences in compliance among the three different strategies, measured by CPAP hours of use
Time Frame: six months follow-up
six months follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
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
six months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

October 7, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (Estimate)

October 27, 2009

Study Record Updates

Last Update Posted (Estimate)

July 27, 2010

Last Update Submitted That Met QC Criteria

July 26, 2010

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7387

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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