Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131547
Status:
COMPLETED
Last Update Posted:
2008-10-16
First Post:
2005-08-17
Brief Title:
Randomized Study of a Simple Weight Loss Program for Obese Patients With Obstructive Sleep Apnea
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
A Randomized Controlled Pilot Study of a Simple Weight Loss Program for Obese Patients With Mild to Moderate Obstructive Sleep Apnea
Status:
COMPLETED
Status Verified Date:
2008-10
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:
The purpose of the study is to determine if weight loss interventions aimed at lifestyle modification dietary education food diary pedometer result in weight loss in patients with mild-moderate obstructive sleep apnea OSA when compared to usual patient care The secondary purpose of the study is to determine if the amount of weight loss achieved in a 6 month period results in improvements in snoring and other symptoms and in the frequency of apnea on overnight monitoring
Detailed Description:
The purpose of the study is to determine if weight loss interventions aimed at lifestyle modification dietary education food diary pedometer result in weight loss in patients with mild-moderate obstructive sleep apnea OSA when compared to usual patient care The secondary purpose of the study is to determine if the amount of weight loss achieved in a 6 month period results in improvements in snoring and other symptoms and in the frequency of apnea on overnight monitoring
Primary Objective
To determine if weight loss interventions aimed at lifestyle modification dietary education food diary pedometer result in weight loss in patients with mild-moderate OSA when compared to usual care
To determine if the amount of weight loss achieved in a 6 month period result in improvements in objective measures of sleep disordered breathing AHI
Secondary Objective
To determine if the weight loss achieved in 6 months result in improvements in OSA symptoms eg snoring sleepiness and quality of life
To determine if metabolic parameters eg lipids glucose improve
To determine if there is improvement in sleep structure and oxygenation during sleep
Primary Objective
To determine if weight loss interventions aimed at lifestyle modification dietary education food diary pedometer result in weight loss in patients with mild-moderate OSA when compared to usual care
To determine if the amount of weight loss achieved in a 6 month period result in improvements in objective measures of sleep disordered breathing AHI
Secondary Objective
To determine if the weight loss achieved in 6 months result in improvements in OSA symptoms eg snoring sleepiness and quality of life
To determine if metabolic parameters eg lipids glucose improve
To determine if there is improvement in sleep structure and oxygenation during sleep
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 |
|---|---|---|---|
| 10596 | None | None | None |