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

This study has been completed.
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00358800
First received: July 28, 2006
Last updated: NA
Last verified: July 2006
History: No changes posted
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnoea Hypopnoea Syndrome
 Device: REMStar Auto with C-Flex

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Randomized Cross Over Study to Compare REMStar Auto With C-Flex to Standard CPAP Therapy in Patients With OSAHS, and to Assess Its Safety, Tolerability and Efficacy and Preference Over CPAP.

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • The study will also compare Polysomnographic Data.
  • This study will compare Cardiopulmonary
  • This study will compare Technician interactions with subject

Estimated Enrollment: 15
Study Start Date: February 2005
Estimated Study Completion Date: December 2005
Detailed Description:

The research question we are exploring is whether the To determine if treatment with C-FLEX is at least equivalent to conventional CPAP therapy as evidenced by standard sleep and breathing variables and To determine if the treatment with C-FLEX has a positive impact as determined by patient and technologist assessment of the PSG experience.

Sleep laboratory rooms will be configured with a RSA device, which can deliver either conventional CPAP or Auto CPAP with C-Flex. Each night the subjects eligible for the trial will be interviewed, and consented for the study. The subjects will be instrumented for polysomnography and PAP titration (with PSG recording of RSA flow, estimated tidal volume, pressure, and estimated leak – via the Analog Output Module). Each subject will be instructed in PAP therapy (using standard methods), and have an appropriate patient interface selected per standard laboratory protocol. Each night, the patients will be randomized to either therapy (conventional CPAP therapy without C-Flex, or RSA C-Flex). PSG will be schedules to take place on consecutive nights when possible. The patient will not be aware of the therapy they will be subjected to, but the night technician will be aware of the therapy choice. On the next night, the subject will receive the alternative therapy (cross-over).

Conventional CPAP without C-Flex CPAP pressure will be set to the therapy pressure determined during a previous titration study. Technicians will record all interactions with the subject, as well as any equipment used in the study. Study data will be analyzed for standard polysomnographic outcome parameters listed below. Patient will complete a visual analog satisfaction questionnaire following the study.

RSA with C-Flex RSA C-Flex will be set with pressure range from 4 to 20 cmH2O. Patients will be arbitrarily set to a C-Flex comfort setting of 3 (maximum pressure relief). If the patient comments about any sensation of ‘breathlessness’ due to the pressure relief, comfort setting may be adjusted to 2 or 1 by the night technician. The subject is not informed of the therapy selected for the study. Technicians will record all interactions with the subject, as well as any equipment used in the study. Study data will be analyzed for standard polysomnographic outcome parameters listed below. Patient will complete a visual analog satisfaction questionnaire following the study.

Demographic Data: Age, gender composition, body mass index, and baseline (diagnostic) AHI will be presented with descriptive statistics. Appropriate statistical analysis will be performed to compare the results of the titration night with REMStar Auto to the night on conventional CPAP. Laboratory Experience: Number of interactions, types of interactions, equipment used and VAS of both patient and technician will be recorded for each subject. Polysomnographic Data, Cardiopulmonary and the process data will be collected and analyzed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00358800

Locations
Canada, British Columbia
UBC Sleep Disorder Program and Sleep Lab, UBC Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Najib Ayas The University of British Columbia
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00358800     History of Changes
Other Study ID Numbers: C04-0474
Study First Received: July 28, 2006
Last Updated: July 28, 2006
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
OSAHS and REMStar Auto with C-Flex

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013