Ignite Creation Date:
2024-05-06 @ 9:25 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02970695
Status:
COMPLETED
Last Update Posted:
2018-10-18
First Post:
2016-05-17
Brief Title:
Auriculotherapy on Older People With Insomnia
Sponsor:
The Hong Kong Polytechnic University
Organization:
The Hong Kong Polytechnic University
Study Overview
Official Title:
Effectiveness of Auriculotherapy on Older People With Insomnia
Status:
COMPLETED
Status Verified Date:
2018-10
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:
Objective To determine the optimum treatment protocol of auriculotherapy AT on the improvement of sleep conditions and quality of life on the elders with insomnia
Research hypothesis The use of combined LAT plus MAT is more effective than MATLAT alone on the improvement of sleep conditions and quality of life in the elderly with insomnia
Design and subjects This is a 3-arm double-blinded randomised trial Subjects aged 65 and exhibit poor sleep conditions are recruited
Interventions Group 1 Subjects will receive a deactivated laser treatment followed by MAT Group 2 Subjects will receive LAT and placebo MAT Group 3 Subjects will receive a combined approach LAT plus MAT
The treatment will be delivered 3 timesweek with a 6-week treatment period on seven specific auricular points
Main outcome measures Sleep conditions and quality of life will be evaluated at baseline end of 6-week treatment and at 6-week 12-week and 6-month follow-up periods
Data analysis Descriptive statistics chi-square analysis ANOVA paired t-test and mixed effect modeling will be conducted as appropriate
Expected results This study would advance our knowledge the optimum treatment protocol of AT in the improvement of the sleep conditions of the elderly population
Research hypothesis The use of combined LAT plus MAT is more effective than MATLAT alone on the improvement of sleep conditions and quality of life in the elderly with insomnia
Design and subjects This is a 3-arm double-blinded randomised trial Subjects aged 65 and exhibit poor sleep conditions are recruited
Interventions Group 1 Subjects will receive a deactivated laser treatment followed by MAT Group 2 Subjects will receive LAT and placebo MAT Group 3 Subjects will receive a combined approach LAT plus MAT
The treatment will be delivered 3 timesweek with a 6-week treatment period on seven specific auricular points
Main outcome measures Sleep conditions and quality of life will be evaluated at baseline end of 6-week treatment and at 6-week 12-week and 6-month follow-up periods
Data analysis Descriptive statistics chi-square analysis ANOVA paired t-test and mixed effect modeling will be conducted as appropriate
Expected results This study would advance our knowledge the optimum treatment protocol of AT in the improvement of the sleep conditions of the elderly population
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