Validation of the Alice PDX Diagnostic System in predicting obstructive sleep apnoea (OSA)

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN62641592

Enrollment

Registered

2010-04-12

Start date

2009-09-28

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive sleep apnoea (OSA) Nervous System Diseases Sleep disorders

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

France, Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026