Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00358800
Status:
COMPLETED
Last Update Posted:
2006-08-01
First Post:
2006-07-28
Brief Title:
REMStar Auto With C-Flex - In-Laboratory Performance v Conventionally Titrated CPAP Therapy Performances and Preferences
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None