Validation of the Alice PDX Diagnostic System in predicting obstructive sleep apnoea (OSA)
| ISRCTN | ISRCTN62641592 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62641592 |
| Secondary identifying numbers | EAME08PDX01 |
- Submission date
- 28/09/2009
- Registration date
- 12/04/2010
- Last edited
- 12/04/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr Georg Nilius
Scientific
Scientific
HELIOS-Klinik Hagen-Ambrock
Ambroker Weg
Hagen
60 58091
Germany
| Phone | +49 (0)2331 974 2000 |
|---|---|
| georg.nilius@helios-kliniken.de |
Study information
| Study design | Single blind randomised crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the sponsor details below to request a patient information sheet |
| Scientific title | Validation of the Alice PDX Diagnostic System in predicting obstructive sleep apnoea (OSA): a single blind randomised crossover study |
| 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(s) | 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 |
| 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 |
| Primary outcome measure | 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 study start date | 28/09/2009 |
| Overall study end date | 28/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 |
| 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 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
Study participating centre
HELIOS-Klinik Hagen-Ambrock
Hagen
60 58091
Germany
60 58091
Germany
Sponsor information
Respironics International, Inc (France) - Philips Home Healthcare Solutions
Industry
Industry
c/o Steven Coughlin
Immeuble Hermes
20 rue Jacques Daguerre
Rueil Malmaison
Paris
92565
France
| Phone | +44 (0)870 423 1318 |
|---|---|
| steven.coughlin@philips.com | |
| Website | http://www.respironics.com |
"ROR" |
https://ror.org/05jz46060 |
Funders
Funder type
Industry
Respironics International, Inc (France) - Philips Home Healthcare Solutions
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
