Condition category
Nervous System Diseases
Date applied
28/09/2009
Date assigned
12/04/2010
Last edited
12/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Georg Nilius

ORCID ID

Contact details

HELIOS-Klinik Hagen-Ambrock
Ambroker Weg
Hagen
60 58091
Germany
+49 (0)2331 974 2000
georg.nilius@helios-kliniken.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EAME08PDX01

Study information

Scientific title

Validation of the Alice PDX Diagnostic System in predicting obstructive sleep apnoea (OSA): a single blind randomised crossover study

Acronym

Alice PDX

Study hypothesis

There will be clinical agreement in the Apnoea Hypopnoea Index (AHI) obtained from simultaneous Alice PDX-in lab and in lab-polysomnographic (PSG) recordings, and the AHI obtained from the PDX-home recording. The differences between the AHI from the PSG and PDX-home will not be greater than two PSGs conducted on two different nights.

Ethics approval

1. Germany: Ethik-Kommission in Witten approved on the 17th March 2009
2. France: Comite de Protection des Personnes Ile de France no. 1 approved on the 27th April 2009

Study design

Single blind randomised crossover study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

Not available in web format, please use the sponsor details below to request a patient information sheet

Condition

Obstructive sleep apnoea (OSA)

Intervention

Baseline demographic information will be collected. At baseline symptoms of snoring, sleepiness and associated features of OSA will be captured on the Berlin and Epworth Questionnaires.

Subjects will undergo three sleep evaluations:
1. The Alice PDX will be used at home on one night
2. The Alice PDX will be used at the same time as one of the PSGs in the sleep laboratory on another night
3. A separate PSG will be carried out in the sleep laboratory without the Alice PDX on a third night
The sequence of the sleep evaluations will be determined randomly. All evaluations will take place within a two week period.

As a minimum the following parameters will be obtained:
1. Total recording time
2. Total sleep time
3. Sleep latency
4. Sleep efficiency
5. Sleep stage distribution
6. Arousals
7. Awakenings
8. Apnoea Hypopnoea Index (AHI)
9. Oxygen saturation

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Apnoea Hypopnoea Index (AHI) measured by polysomnography and polygraphy (Alice PDX). Measured over three nights in a random order of either:
1. PDX at home
2. PDX and In-Lab PSG at the same time
3. In-Lab PSG

Secondary outcome measures

1. Apnoea
2. Hypopnoea
3. Supine AHI
4. Total recording time
5. Arousals
6. Desaturation

All will be measured by polysomnography and polygraphy (Alice PDX) as detailed for the primary outcome measures.

Overall trial start date

28/09/2009

Overall trial end date

28/09/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female patients greater than 21 years of age
2. Suspected obstructive sleep apnoea (OSA) or (or suspected simple snorers)
3. Ability to provide consent
4. Ability and willingness to follow study procedures

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Previous diagnosis of OSA
2. Presence or suspicion of another sleep disorder
3. Acute illness (including cardiac and pulmonary diseases), medically complicated or medically unstable
4. Patients requiring supplemental oxygen or mechanical ventilation
5. Drug abuse (both acute and chronic) according to the Drug Abuse Screening Test (DAST) criteria
6. Alcohol abuse (both acute and chronic) according to the CAGE criteria
7. Intake of excessive central relevant drugs, sedatives, or other drugs which impair sleep, as judged by the investigator
8. Psychiatric or neurological diseases resulting in impairment of sleep
9. Thyroidal dysfunction
10. Chronic pain syndromes
11. Chronic cardiac, pulmonary or other internal diseases resulting in impairment of sleep
12. Unwilling to participate in the study
13. Participation in another clinical study in the past 4 weeks

Recruitment start date

28/09/2009

Recruitment end date

28/09/2010

Locations

Countries of recruitment

France, Germany

Trial participating centre

HELIOS-Klinik Hagen-Ambrock
Hagen
60 58091
Germany

Sponsor information

Organisation

Respironics International, Inc (France) - Philips Home Healthcare Solutions

Sponsor details

c/o Steven Coughlin
Immeuble Hermes
20 rue Jacques Daguerre
Rueil Malmaison
Paris
92565
France
+44 (0)870 423 1318
steven.coughlin@philips.com

Sponsor type

Industry

Website

http://www.respironics.com

Funders

Funder type

Industry

Funder name

Respironics International, Inc (France) - Philips Home Healthcare Solutions

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes