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A Randomized Study to Compare Polysomnography With Overnight Home Oximetry and Auto - CPAP for Sleep Apnea

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ClinicalTrials.gov Identifier: NCT00254059
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : November 15, 2005
Sponsor:
Information provided by:
University of British Columbia

Study Description
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Brief Summary:
This study will look at an alternative new pathway for diagnosis and treatment based on simple procedures in the patient's own home compared with the current conventional laboratory based pathway. The purpose is to determine whether all patients with OSA require the more elaborate laboratory procedures, or whether a subgroup can be managed more simply.

Condition or disease Intervention/treatment Phase
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 Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 1. The study will also compare CPAP pressure between the two groups after 3 months of therapy.
  2. 2. This study will compare Epworth Sleepiness Score, arousal index and sleep efficiency index between the two groups after 3 months of therapy.
  3. 3. This study will compare Sleep Apnea Quality of Life Index between the two groups after 3 months of therapy.
  4. 4. It will compare the change in Sleep Apnea Quality of Life Index from baseline to follow-up between the two groups.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Age > 18 years

  • Residence in the Lower Mainland
  • History and physical examination findings compatible with OSAHS
  • Normal spirometry. (This is necessary to avoid decreased specificity of overnight oximetry attributable to underlying lung disease)
  • Epworth Sleepiness Scale > 10

Exclusion Criteria:

  • Age < 18 years
  • Pregnancy
  • Other known disorders that cause daytime sleepiness
  • Requiring sedative/hypnotic medications
  • Psychiatric disorder
  • Life threatening co-morbidity e.g. chronic lung disease, coronary artery disease - unstable angina, recent myocardial infarction, heart failure, seizure disorder, and previous motor vehicle accident attributed to hypersomnolence
  • Language barrier
  • Inability to give informed consent
  • Contraindication to nasal CPAP therapy
  • Previous treatment of OSAHS with nasal CPAP, oral appliance therapy or corrective upper airway surgery.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00254059


Locations
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Canada, British Columbia
Vancouver Coastal Health Research Institute, Respiratory Division
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Frank Ryan, MD University of British Columbia
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00254059    
Other Study ID Numbers: C03-0079
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: November 15, 2005
Last Verified: November 2005
Keywords provided by University of British Columbia:
OSAHS, OSA, CPAP, polysomnography, overnight oximetry, Obstructive sleep apnea, apnea hypopnea index, AHI, Obstructive Sleep Apnea Hypopnea Syndrome
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases