Ignite Creation Date:
2024-05-05 @ 11:56 PM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01455077
Status:
UNKNOWN
Last Update Posted:
2011-10-19
First Post:
2011-10-15
Brief Title:
Portable Monitoring Device for the Diagnosis of Sleep Apnea in Obese Patients
Sponsor:
Associacao Fundo de Incentivo a Psicofarmcologia
Organization:
Associacao Fundo de Incentivo a Psicofarmcologia
Study Overview
Official Title:
Validation of a Portable Monitoring System for the Diagnosis of Obstructive Sleep Apnea Syndrome in Patients With Level II and III Obesity
Status:
UNKNOWN
Status Verified Date:
2011-10
Last Known Status:
RECRUITING
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:
Introduction The portable monitoring system PMS recording of cardiopulmonary parameters level III of ASDA has been validated in subjects with high probability of Obstructive Sleep Apnea OSA without comorbidities
However there is not any study evaluating this system when OSA is associated with morbid obesity so the validation of PMS will be very useful in order to properly work-up this highly risk population
Objective
To evaluate the accuracy of level III type of PMS - Stardust STD on patients with level II and III of obesity and high clinical suspicion of OSA
MethodsParticipants with BMI 35 kgm2 and with suspicion of OSA will consecutively be selected from an Outpatients Sleep Clinic of UNIFESP They will be randomized for the following order of recordings
1 STD at home for 1 night 2 STD in the sleep lab simultaneous to PSG AHI will be taken for subsequent analysisa AHI PSG b AHI STD -lab and c AHI STD- home
However there is not any study evaluating this system when OSA is associated with morbid obesity so the validation of PMS will be very useful in order to properly work-up this highly risk population
Objective
To evaluate the accuracy of level III type of PMS - Stardust STD on patients with level II and III of obesity and high clinical suspicion of OSA
MethodsParticipants with BMI 35 kgm2 and with suspicion of OSA will consecutively be selected from an Outpatients Sleep Clinic of UNIFESP They will be randomized for the following order of recordings
1 STD at home for 1 night 2 STD in the sleep lab simultaneous to PSG AHI will be taken for subsequent analysisa AHI PSG b AHI STD -lab and c AHI STD- home
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| STD obesity | None | None | None |
| Portable monitoring system for | None | None | None |