Measurement location for the indices of obstructive apnea / hypopnea frequency during Continuous Positive Airway Pressure (CPAP) therapy

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12606000486527
• Lead Sponsor: DiagnoseIT Pty Ltd, Sydney, NSW, Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2006-04-28
• Study Start: 2006-11-24
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Subjects must satisfy the following inclusion criteria:Previously diagnosed with moderate-severe obstructive sleep apnea (RDI>15)Compliant CPAP use for at least 3 months durationCompliance: CPAP use > 4 hours per night for at least 5 nights per week No significant problems with CPAP therapy such as mask/mouth leak or severe nasal congestion. English speaking.

Exclusion Criteria

Other sleep disorders including:PLMD Untreated RLS >10 Central apnoeas/hr on diagnostic sleep studyNeurological disordersPsychiatric disordersSignificant medical complaint including:Severe cardiovascular disease Congestive heart failure Significant lung disease (e.g., chronic obstructive pulmonary disease) Daytime hypoxemia and respiratory failure from any cause Prominent nocturnal desaturation other than from OSA (e.g., obesity hypoventilation syndrome).

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of differences in Apnea Hypopnea Index (AHI) measured at four sites during overnight polysomnography (PSG) of subjects established on CPAP therapy. AHI will be measured during a two-night titration protocol (random order) using polysomnography in the sleep laboratory. Subjects will be connected to the CPAP device for the entirety of the PSG recording on both nights.[Polysomnography data will be recorded from Lights Out to Lights On (approximately 8 hour recording) during overnight PSG. ]