Comparison of Breathing Event Detection by a Continuous Positive Airway Pressure Device to Clinical Polysomnography

NCT00836758 | Completed Results

• 1 other identifier: EDILP-2008-SST-01
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

The study is to compare the performance of a CPAP (continuous positive airway pressure) device to a clinical polysomnography (PSG) in identifying breathing events in patients with obstructive sleep apnea.

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Apnea-hypopnea Indices (AHI) as Determined by Polysomnography (PSG) vs Automatic Event Detection (AED ) Algorithm

  Apnea-hypopnea index (AHI) is the combined average number of apneas and hypopneas that occur per hour of sleep. The Apnea index (AI) is the average number of apneas that occur per hour of sleep. The Hypopnea index (HI) is the average number of hypopneas that occur per hour of sleep. The PSGs were manually scored to determine the apnea-hypopnea index. This value was then compared to the PAP device which utilized the AED algorithm to determine the apnea-hypopnea index.

  one night

Secondary Outcomes (1)

• Methodological Comparisons of AHI, Apnea Index (AI) and Hypopnea Index (HI) as Determined by Intra-class Correlation (ICC)

  one night

Study Arms (1)

CPAP Device

EXPERIMENTAL

Breathing event detection (AED) by the CPAP device will be compared to breathing event detection by a simultaneous PSG (manual PSG scoring).

Device: Analysis with AED and manual PSG scoring

Interventions

Analysis with AED and manual PSG scoring DEVICE

The CPAP device will be set-up at a sub-therapeutic pressure and will remain at this pressure for the entire night, if tolerated. Then the events will be analyzed with Automatic Event Detection (AED) and manual PSG scoring.

CPAP Device

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-75
• Diagnosis of OSAHS with a baseline AHI ≥ 15 events/hr of sleep assessed January 01, 2007 or later
• CPAP prescription of 8cm of H20 or higher
• Able and willing to provide written informed consent
• Native English speaker

You may not qualify if:

• Participation in another interventional research study within the last 30 days
• Major medical or psychiatric condition that would interfere with the demands of the study and adherence to PAP. Examples include unstable cardiovascular disease (Class III / IV CHF), neuromuscular disease, cancer, and renal failure.
• Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe continuous positive airway pressure (COPD) or other pulmonary disorders, or any condition with an elevation of arterial carbon dioxide levels (\> 45 mmHg) while awake, or subjects requiring continuous oxygen therapy.
• Surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
• Surgery at any time for the treatment of OSAHS such as uvulopalatopharyngoplasty (UPPP)
• Presence of untreated or poorly managed,non-OSAHS related sleep disorders:
• moderate to severe periodic limb movements(≥ 30/hr with symptoms or arousals)
• arousals associated with periodic limb movements \> 10 per hour or
• anyone experiencing chronic and severe insomnia.
• Consumption of ethanol immediately prior to the research PSG

Sponsors & Collaborators

• Philips Respironics: lead

Study Sites (1)

Shands and UF Sleep Disorder Center

Gainesville, Florida, 32606, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Richard B. Berry, MD
• Organization: University of Florida

sleep_doc@msn.com

352-262-1575

Study Officials

• Richard Berry, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants wore a PAP device and had a PSG at the same time. These participants had their PSG data compared to the PAP data.

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: February 4, 2009
• Study Start: February 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: January 16, 2019
• Results First Posted: January 16, 2019

Record last verified: 2018-12

Locations

US (1)