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

NCT00254059 | Completed

• 1 other identifier: C03-0079
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

OSAHS, OSA, CPAP, polysomnography, overnight oximetry, Obstructive sleep apnea, apnea hypopnea index, AHI, Obstructive Sleep Apnea Hypopnea Syndrome

Outcome Measures

Primary Outcomes (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 Outcomes (4)

• 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.

Interventions

Ambulatory diagnosis and titration with nasal CPAP using over night oxymetry and auto CPAP and vs conventional diagnosis and titration using polysomnography PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver Coastal Health Research Institute, Respiratory Division

Vancouver, British Columbia, Canada

Location

Related Publications (1)

• Mulgrew AT, Fox N, Ayas NT, Ryan CF. Diagnosis and initial management of obstructive sleep apnea without polysomnography: a randomized validation study. Ann Intern Med. 2007 Feb 6;146(3):157-66. doi: 10.7326/0003-4819-146-3-200702060-00004.

  PMID: 17283346 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Microcephaly, Primary Autosomal Recessive, 6

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Frank Ryan, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 10, 2005
• First Posted: November 15, 2005
• Study Completion: December 1, 2004
• Last Updated: November 15, 2005

Record last verified: 2005-11

Locations

CA (1)