The aim of this study is elucidating the effects of rocking on quality and polysomnographic measures of sleep in primary insomnia patients. In this non-randomized study, 12 patients with insomnia would be admitted for 3 consecutive nights at sleep research lab. Inclusion criteria is primary insomnia and age from 20 to 60 years old and exclusion criteria is motion sickness and internal ear disease. The first night is for adaptation of patients with the sleep lab environment, the second night for performing polysomnography on the rocking bed in a constant state and the third night for performing polysomnography during rocking motion.Duration of intervention (rocking ) is total polysomnographic recording time in the third night
Patients data, including sleep quality questionnaires and polysomnogrphic parameters are compared between the second and third night.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014102210218N3
Registration date:2014-12-24, 1393/10/03
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-12-24, 1393/10/03
Registrant information
Name
Mohammad Reza Saebipour
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3238 1562
Email address
m-saebipour@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-01-01, 1393/10/11
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of rocking on an a programmable rocking bed on quality and polysomnogrphic measures of sleep in insomnia patients
Public title
The effect of rocking on quality of sleep in insomnia
Tehran University of Medical Sciences Ethical Committee
Street address
Research deputy, room no:601,TUMS central building, 6th floor, Ghods Str. Keshavarz blvd.
City
Tehran
Postal code
Approval date
2014-07-05, 1393/04/14
Ethics committee reference number
93-01-178-25518
Health conditions studied
1
Description of health condition studied
Insomnia
ICD-10 code
F51.0
ICD-10 code description
Nonorganic insomnia A condition of unsatisfactory quantity and/or quality of sleep, which persists for a considerable period of time, including difficulty falling asleep, difficulty staying asleep, or early final wakening. Insomnia is a common sympto
Primary outcomes
1
Description
Sleep Onset Latency
Timepoint
Before and during the intervention
Method of measurement
Polysomnography
2
Description
Sleep Quality
Timepoint
Befor and after the intervention
Method of measurement
sleep quality questionnaire
3
Description
sleep spindle count
Timepoint
Before and during the intervention
Method of measurement
Embla & MATLAB software
Secondary outcomes
empty
Intervention groups
1
Description
Rocking
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Birjand University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Saebipour
Street address
Ghaffari Street
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Khosro Sadeghniiat
Street address
Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Birjand University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Saebipour
Position
MD PhD of Neurosciences
Other areas of specialty/work
Street address
Ghaffari Street
City
Birjand
Postal code
Phone
+98 21 5566 9300
Fax
Email
saebipour@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Saebipour
Position
MD PhD of Neurosciences
Other areas of specialty/work
Street address
Ghaffari Street
City
Birjand
Postal code
Phone
+98 21 5566 9300
Fax
Email
saebipour@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Saebipour
Position
MD PhD of Neurosciences
Other areas of specialty/work
Street address
Ghaffari Street
City
Birjand
Postal code
Phone
+98 21 5566 9300
Fax
Email
saebipour@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)