Nightmare disorder is a parasomnia that affects around 4% of population.it can impair quality of life and sleep, predispose to insomnia, daytime sleepiness and fatigue. Based on DSM-IV definition nightmares are extremely frightening dreams that awakes the sleeper with a detailed memory and a quick orientation afterwards. Trauma nightmares are one of the important characterizations of Post-traumatic stress disorder. Several studies shows prazosin efficacy on reduction of these nightmares and significant sleep improvement by decreasing adrenergic tone in CNS. Therefor we decided to investigate effects of tamsulosin in a double-blind placebo controlled clinical trial on nightmares (and not only those are PTSD but also every patient who have sever nightmares) which have a better pharmacokinetic versus prazosin. 20 patients suffering from nightmare disorder and fulfill inclusion criteria are targeted by scoring disturbing dreams and nightmares severity index (DDNSI) questionnaire for 10week assessment following: 4week tamsulosin or placebo 2week wash out(neither tamsulosin nor placebo) 4week tamsulosin or placebo. Patients At week 0(baseline), weeks 4, 6, 10 will have an appointment to assess by DDNSI and ask about sleep improvement or any side effect. Inclusion criteria: patients who have nightmare disorder and get necessary score on mentioned index and have complains about nightmares and would get benefit from therapy. Exclusion criteria: patients who have a low blood pressure, sensitivity to tamsulosin, occurrence of serious side effect. We expect tamsulosin versus placebo shows a great reduction on DDNSI which means disturbing dreams and nightmares decreases by tamsulosin and probably would have beneficial effect for who have nightmare disorder.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412163106N21
Registration date:2015-01-14, 1393/10/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-14, 1393/10/24
Registrant information
Name
Farshad Hashemian
Name of organization / entity
Pharmaceutical Sciences Branch, Islamic Azad University (IAU)
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 0037
Email address
hashemian.f@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Pharmaceutical sciences branch of Islamic Azad university
Expected recruitment start date
2014-12-06, 1393/09/15
Expected recruitment end date
2015-03-11, 1393/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation effects of Tamsulosin on disturbing dreams and nightmares: a cross over pilot study
Public title
Effect of tamsulosin on nightmares
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. Nightmare disorder Patients who are interested in treatment and earn necessary score on disturbing dreams and nightmares severity index (DDNSI) questionnaire; 2. No concomitant disease that limit the use of tamsulosin; 3. Quality of life and sleep impairment make drug therapy beneficial; 4. No concomitant drug therapy which have life threatening interactions with tamsulosin
Exclusion criteria: 1. Patients who have a low blood pressure occurrence serious side effect; 2. Patients who are not interested for treatment; 3. Patients who have sensitivity to sulfa drugs and tamsulosin or ingredients; 4. Occurrence of serious side effect like severe orthostatic hypotension; 5. Patients with cardiovascolar disease.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Pharmaceutical science branch of Islamic Azad University
Street address
No.99, Yakhchal street, Dr. Shariati Avenue
City
Tehran
Postal code
Approval date
2014-08-20, 1393/05/29
Ethics committee reference number
6125
Health conditions studied
1
Description of health condition studied
Nightmare disorder
ICD-10 code
F51.5
ICD-10 code description
Nightmares
Primary outcomes
1
Description
Reduction or totally disappearing disturbing dreams and nightmares
Timepoint
Weeks: 0, 4, 6 and 10
Method of measurement
Disturbing dreams and nightmares severity index questionnaire and interviewing about sleep improvement
Secondary outcomes
1
Description
Reported side effectd-hypotension
Timepoint
Weeks: 0, 4, 6 and 10
Method of measurement
Blood pressure monitoring
Intervention groups
1
Description
This study is designed crossover so the following will be done: 4 weeks tamsulosin or placebo 0.4mg capsule every night; 2 weeks wash out (neither tamsulosin nor placebo) then 4 weeks placebo or tamsulosin 0.4mg capsule every night. Patients are instructed to take the drug at least half an hour after dinner with a glass of water.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pharmaceutical science branch of Islamic Azad university
Full name of responsible person
Negin Naderifar
Street address
No.99, Yakhchal street, Dr. Shariati Avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic azad university of pharmaceutical sciense
Full name of responsible person
Dr. Sepideh Arbabi Bigdeli
Street address
No.99, Yakhchal street, Dr. Shariati Avenue Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic azad university of pharmaceutical sciense
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pharmaceutical science branch of Islamic Azad university
Full name of responsible person
Dr. Farshad Hashemian
Position
Associate Professor
Other areas of specialty/work
Street address
No.99, Yakhchal street, Dr. Shariati Avenue
City
Tehran
Postal code
Phone
+98 21 2264 0056
Fax
Email
hashemian.f@iaups.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)