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

Completed

• Conditions: Obstructive sleep apnoea (OSA); Nervous System Diseases; Sleep disorders

• Registration Number: ISRCTN62641592
• Lead Sponsor: Respironics International, Inc (France) - Philips Home Healthcare Solutions

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-12
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified