A Randomized Study to Compare Polysomnography With Overnight Home Oximetry and Auto – CPAP for Sleep Apnea
Obstructive Sleep Apnea
Procedure: Ambulatory diagnosis and titration with nasal CPAP using over night oxymetry and auto CPAP and vs conventional diagnosis and titration using polysomnography
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Study to Compare Polysomnography With Overnight Home Oximetry and Auto – CPAP for Diagnosis and Nasal CPAP Titration in Patients With a High Probability of Obstructive Sleep Apnea.|
- The primary outcome measurement will be apnea-hypopnea index (AHI) during a full night polysomnogram performed on the effective nasal CPAP pressure after 3 months of nasal CPAP therapy.
- 1. The study will also compare CPAP pressure between the two groups after 3 months of therapy.
- 2. This study will compare Epworth Sleepiness Score, arousal index and sleep efficiency index between the two groups after 3 months of therapy.
- 3. This study will compare Sleep Apnea Quality of Life Index between the two groups after 3 months of therapy.
- 4. It will compare the change in Sleep Apnea Quality of Life Index from baseline to follow-up between the two groups.
|Estimated Study Completion Date:||December 2004|
The research question we are exploring is whether the conventional approach is better in terms of successful treatment, compliance with treatment, and quality of life. There will be 2 arms to the study. Subject will be randomly assigned to either one of the following two treatment options: 1) the conventional investigation and nasal CPAP treatment pathway comprising 2 overnight sleep studies, one for diagnosis and one for determining the required level of nasal CPAP treatment 2) experimental pathway that uses a simplified home study (overnight oximetry), together with a machine that automatically adjusts the nasal CPAP pressure to the required amount, and a careful follow-up during the first 2 weeks of treatment.
Procedures: The study protocol will require the subject to complete the following procedures which are part of routine clinical practice: History and Physical Examination by a physician, Home Oximetry (This simple test involves wearing an oxygen probe gently wrapped around subject’s finger during a night’s sleep to continuously measure the amount of oxygen in blood and detect obstructions of subject’s breathing. The probe is easily applied by the subject and requires no supervision), Spirometry (simple non-invasive breathing test), Standardized Sleepiness Questionnaires, Orientation and Education regarding nasal CPAP therapy, and compliance monitoring, Overnight polysomnography (This is the procedure that requires subject to spend a night in the sleep laboratory with a variety of painless and non-invasive monitoring devices attached to the body. The purpose is to obtain detailed information about subject’s sleep quality, breathing, heart function, and body movements during sleep. Subject will be continuously monitored by a trained technologist during this procedure.). The following procedures are not routine and subject may be required to complete some or all of them depending on which pathway assigned to. Follow-up visits to the Clinic on Days 7 and 14 of nasal CPAP treatment for adjustments of nasal CPAP pressure as required (this could also be done at home), Repeat Home Oximetry as required, Quality of Life Questionnaire.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254059
|Canada, British Columbia|
|Vancouver Coastal Health Research Institute, Respiratory Division|
|Vancouver, British Columbia, Canada|
|Principal Investigator:||Frank Ryan, MD||University of British Columbia|