REMStar Auto With C-Flex - In-Laboratory Performance v. Conventionally Titrated CPAP Therapy: Performances and Preferences

NCT00358800 | Completed

• 1 other identifier: C04-0474
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the use of REMStar Auto with C-Flex (RSA C-Flex) therapy in subjects with previously diagnosed obstructive sleep apnea / hypopnea syndrome, during in-laboratory studies. The study will determine the ability of RSA C-Flex therapy to effectively treat the sleep apnea events. Mask leak and key sleep parameters will be monitored, and are expected to be improved with C-Flex vs. CPAP therapy. Satisfaction from both patient and technician will also be monitored.

Conditions

Obstructive Sleep Apnoea Hypopnoea Syndrome

Keywords

OSAHS and REMStar Auto with C-Flex

Outcome Measures

Primary Outcomes (1)

• This study will compare apnea-hypopnea index (AHI) and standard sleep and breathing variables while on nasal CPAP vs REMStar Auto with C-Flex. Subject himself acts his own control

Secondary Outcomes (3)

• The study will also compare Polysomnographic Data.

• This study will compare Cardiopulmonary

• This study will compare Technician interactions with subject

Interventions

REMStar Auto with C-Flex DEVICE

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18
• Primary medical diagnosis Obstructive Sleep Apnea / Hypopnea Syndrome
• AHI ≥ 15 events•hr-1 of sleep
• Ability to provide consent
• Successful completion of a conventional CPAP titration in a sleep laboratory under polysomnographic conditions (success defined by reduction of AHI to \< 5•hr-1 during therapeutic portion of study, in supine position and in REM and NREM sleep state).

You may not qualify if:

• Patients who are medically complicated or who are medically unstable.
• Patients who have been on chronic CPAP or BiPAP therapy or require oxygen therapy.
• Patients with respiratory failure or respiratory insufficiency or who have elevated arterial carbon dioxide levels while awake.
• Patients who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
• Patients with non-OSA sleep disorders.
• Patients in whom PAP therapy is otherwise medically contraindicated.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

UBC Sleep Disorder Program and Sleep Lab, UBC Hospital

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Najib Ayas

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 28, 2006
• First Posted: August 1, 2006
• Study Start: February 1, 2005
• Study Completion: December 1, 2005
• Last Updated: August 1, 2006

Record last verified: 2006-07

Locations

CA (1)