Obstructive Sleep Apnoea Hypopnoea Syndrome Clinical Trial
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.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01525160 -
New Markers to Measure Clotting in Patients With the Obstructive Sleep Apnoea Hypopnoea Syndrome
|
N/A |