1. Home
  2. Approved trials
  3. » فارسی

The effect and no effect of Treatment of sleep disorders on cognitive function, quality of life and CD4 + counts in people with HIV+ / AIDS

Protocol summary

Summary
This study is a double blind trial that aimed to determine the effect and no effect of Treatment sleep disorders on cognitive function, quality of life and CD4 + counts in people with HIV + / AIDS who are under treated with methadone. Inclusion criteria will be having a sleep disorder, Catching HIV + / AIDS, Being treated with methadone. Consumption of any drug or medication that causes sleep disturbances will be exclusion criteria. Statistical population will be included all patients with HIV + / AIDS who referred to methadone treatment centers to provide Methadone Maintenance Therapy in Kermanshah, Iran. At first, all participants will be interviewed and given some explanations about the project to them. After obtaining informed consent, these people will be enrolled. The statistical population will be included 60 patients. Based on the score that obtained in Pittsburgh Sleep Quality Index, Patients will be randomly divided into three groups of 20 randomly. All of them will respond to the Quality of Life and cognitive function scales; Also the number of CD4 + will be measured by flow cytometry. The first group will be treated with trazodone 25 to 100mg daily, the second group will be trained for sleep hygiene (two hours each time, weekly) and the third group will be a combination of sleep hygiene education and treatment with trazodone. All subjects in all three groups will be re-evaluated by completing mentioned questionnaires at baseline, 4 weeks and at the end of the study (8 weeks after baseline) and quality of life, cognitive function, CD4 + will be assessed again.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016110923705N8
Registration date: 2016-11-27, 1395/09/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-11-27, 1395/09/07
Registrant information
Name
Mostafa Alikhani
Name of organization / entity
Kermanshah University of Medical Sciences - Substance Abuse Prevention Research Center
Country
Iran (Islamic Republic of)
Phone
+98 838264513
Email address
mo.alikhani@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2016-11-10, 1395/08/20
Expected recruitment end date
2017-11-10, 1396/08/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect and no effect of Treatment of sleep disorders on cognitive function, quality of life and CD4 + counts in people with HIV+ / AIDS
Public title
The effect of Treatment of sleep disorders on cognitive function, quality of life and CD4 + counts in people with HIV+ / AIDS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having a sleep disorder; Patients treated with methadone; Having HIV+ / AIDS; Diagnose of sleep disorders by a psychiatrist that are not treated for sleep disorders. Exclusion criteria: Use of any drug or medication that impairs sleep; any other psychiatric and physical illness
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2016-07-13, 1395/04/23
Ethics committee reference number
kums.rec.1395.255

Health conditions studied

1

Description of health condition studied
HIV+/AIDS
ICD-10 code
B20
ICD-10 code description
Human immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases

Primary outcomes

1

Description
cognitive function
Timepoint
The beginning of the study (baseline), week four and end of the study (week eight)
Method of measurement
StroopTest

2

Description
quality of life
Timepoint
The beginning of the study (baseline), week four and end of the study (week eight)
Method of measurement
World health organization quality of life brief Scale

3

Description
CD4+
Timepoint
The beginning of the study (baseline), week four and end of the study (week eight)
Method of measurement
By Flow cytometry

Secondary outcomes

empty

Intervention groups

1

Description
In the experimental group 2, the participant will receive Sleep hygiene education(2 hours weekly). then questionnaire will be redistributed at baseline,4 weeks later, and at the end of the study (8 weeks after the start of the study), ; And the quality of life, cognitive function, CD4 + count will be measured
Category
Behavior

2

Description
In the experimental group 1, the participant will receive trazodone drug 25 mg to 100mg daily. then questionnaire will be redistributed at baseline,4 weeks later, and at the end of the study (8 weeks after the start of the study), ; And the quality of life, cognitive function, CD4 + count will be measured.
Category
Treatment - Drugs

3

Description
In the experimental group 3, the participant will be undertreated by a combination of treatment with trazodone and sleep hygiene education ). then questionnaire will be redistributed at baseline,4 weeks later, and at the end of the study (8 weeks after the start of the study), ; And the quality of life, cognitive function, CD4 + count will be measured
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Dr.Jalal Shakeri
Street address
Farabi Hospital, Isar square
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr.Habib Allah Khazaie
Position
Psychiatrist
Other areas of specialty/work
Street address
Farabi Hospital, Isar square
City
Kermanshah
Postal code
Phone
+98 83 3826 0700
Fax
Email
ha_khazaie@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Alireza Ebrahimi
Position
Psychiatrist
Other areas of specialty/work
Street address
Farabi Hospital, Isar square
City
Kermanshah
Postal code
Phone
+98 83 3826 4513
Fax
Email
alirezaebrahimi1344@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Vahid Farnia
Position
Psychiatrist
Other areas of specialty/work
Street address
Farabi Hospital, Isar square
City
Kermanshah
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...