Investigating the effect of different doses of Horse Chestnut seed extract nasal spray on the symptoms of sleep apnea
Design
Four-arm parallel-group randomized trial with double-blinded outcome assessment
Settings and conduct
Patients with sleep apnea referring to the sleep clinics of Razi Birjand, Ibn Sina Hospital, Mashhad, Ahvaz, and Kermanshah with a score of 4 or more on the Petersburg Sleep Questionnaire and having respiratory apnea more than 5 times per hour will be included in the study. Three groups will be in the intervention group and one group will be the control group with placebo.
Participants/Inclusion and exclusion criteria
inclusion criteria: Sleep apnea with a score of 6 or more on the Petersburg Sleep Questionnaire, a stop-bang test score of 4 or more and respiratory apnea with more than five obstructive apneas per hour
Exclusion criteria: patients with a history of acute liver and kidney disease or liver and kidney failure, pregnant and lactating, and children under 10 years of age, and patients taking anticoagulant drugs and having a cardiac pacemaker, or a history of any sensitivity to any chemical compound or herbal or medicinal and patients with a history of taking various narcotic and psychoactive drugs or patients with dementia symptoms that are difficult to judge
Intervention groups
Patients suffering from sleep apnea receiving two puffs in each nostril of intranasal spray containing Indian chestnut seed extract every 8 hours for 30 days. Standardized extract equivalent to 1.25, 2.5, and 5 mg/L aescin.
Main outcome variables
Pittsburgh Sleep Quality Index
General information
Reason for update
Acronym
PSMS
IRCT registration information
IRCT registration number:IRCT20240526061903N1
Registration date:2024-08-05, 1403/05/15
Registration timing:registered_while_recruiting
Last update:2024-08-05, 1403/05/15
Update count:0
Registration date
2024-08-05, 1403/05/15
Registrant information
Name
zahra kiani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 565 8705
Email address
kiani.za@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-06-20, 1403/03/31
Expected recruitment end date
2025-06-21, 1404/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Aesculus hippocastanum intranasal spray on improving the symptoms of obstructive sleep apnea
Public title
The effect of horse chestnut spray on sleep apnea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a history of sleep disorder and nocturnal snoring and frequent night awakenings and daily fatigue or uncontrolled blood pressure that is mentioned in the history of sleep apnea
The number of apneas greater than five obstructive apneas per hour
Stop-Bang test score of 4 or more
Have a score of 6 or more on the Petersburg Sleep Questionnaire
Exclusion criteria:
Acute renal and liver disease
Pregnancy
Breastfeeding
Age under 10 years
Receiving anticoagulant drugs
Having cardiac pace maker
Hypersensitivity to any drugs
Substance abuse
Dementia
History of liver and kidney diseases
Age
From 11 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
It is a completely randomized block design including of ABCD. The patients are randomly allocated to the experimental units inside each block.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind, so that the researcher and the subject are not aware of the allocation status. The intervention and the placebo will be similar in appearance.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Birjand University of Medical Sciences (Ethics Committee)
Street address
Ghafari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2023-11-27, 1402/09/06
Ethics committee reference number
IR.BUMS.REC.1402.361
Health conditions studied
1
Description of health condition studied
Obstructive sleep apnea
ICD-10 code
G47.33
ICD-10 code description
Obstructive sleep apnea (adult) (pediatric)
Primary outcomes
1
Description
Changes in Beck Depression Inventory (BDI)
Timepoint
before, 1 and 2 months after the intervention
Method of measurement
Beck Depression Inventory questionnaire
2
Description
changes in Hamilton Anxiety Inventory (HRSA)
Timepoint
before, 1 and 2 months after the intervention
Method of measurement
Hamilton Anxiety Inventory questionnaire
3
Description
changes in Pittsburgh Sleep Quality Questionnaire (PSQI)
Timepoint
before, 1 and 2 months after the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
4
Description
Quality of Life Questionnaire
Timepoint
before, 1 and 2 months after the intervention
Method of measurement
Quality of Life Questionnaire
5
Description
Insomnia and Daily Fatigue Severity Questionnaire
Timepoint
before, 1 and 2 months after the intervention
Method of measurement
Insomnia and Daily Fatigue Severity Questionnaire
6
Description
Brain Map, and EEG
Timepoint
before, 1 and 2 months after the intervention
Method of measurement
performing EEG and brain map
7
Description
changes in Stop-Bang sleep apnea questionare
Timepoint
before, 1 and 2 months after the intervention
Method of measurement
Stop-Bang sleep apnea questionare
8
Description
Determining the number of apnea and hypopnea and changes in heart rate and oxygen saturation
Timepoint
before, 1 and 2 months after the intervention
Method of measurement
Polysomnography
9
Description
changes in serum levels of CBC، ALT، AST، TSH، Bu، Cr، ESR و CRP ،NF-κB؛ IL-6 IL 1 , TNF
Timepoint
before, 1 and 2 months after the intervention
Method of measurement
assay of serum level
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients suffering from obstructive sleep apnea receive two puffs in each nostril of a spray containing Indian chestnut seed extract equivalent to 1.25 mg/L of aescin every 8 hours for 30 days.
Category
Treatment - Drugs
2
Description
Control group: Patients suffering from obstructive sleep apnea receive spray containing sodium chloride 0.9% two puffs in each nostril every 8 hours for 30 days.
Category
Placebo
3
Description
Intervention group 2: Patients suffering from obstructive sleep apnea receive two puffs in each nostril of a spray containing Indian chestnut seed extract equivalent to 2.5 mg/L of aescin every 8 hours for 30 days.
Category
Treatment - Drugs
4
Description
Intervention group 3: Patients suffering from obstructive sleep apnea receive two puffs in each nostril of a spray containing Indian chestnut seed extract equivalent to 5 mg/L of aescin every 8 hours for 30 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology Clinic of Razi Birjand Hospital
Full name of responsible person
Seyed Mohammad Mousavi Mirzaei
Street address
Razi hospital, Ghafari street
City
Birjand
Province
South Khorasan
Postal code
9717853111
Phone
+98 56 3162 6000
Fax
+98 56 3162 6363
Email
razihospital@bums.ac.ir
Web page address
https://razi.bums.ac.ir/
2
Recruitment center
Name of recruitment center
Sleep Disorders Clinic, Ibn Sina Center, Mashhad
Full name of responsible person
Fariborz Rezai nasab
Street address
Hor Ameli street
City
Birjand
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3711 2709
Fax
+98 51 3711 2545
Email
ISH.IT@MUMS.AC.IR
Web page address
https://sina.mums.ac.ir/
3
Recruitment center
Name of recruitment center
Air Pollution and Respiratory Diseases Research Center, Ahvaz Jundishapur University of Medical Scie
Full name of responsible person
Maryam Hadadzade Shoushtari
Street address
Azadegan Street
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3221 5574
Fax
+98 61 3222 5763
Email
aprdrc@ajums.ac.ir
Web page address
https://aprdrc.ajums.ac.ir/
4
Recruitment center
Name of recruitment center
sleep disorders research center
Full name of responsible person
Habibollah Khazai
Street address
Farabi Medical Education Center, Dolat-Abad Boulevard,
City
Kermanshah
Province
Kermanshah
Postal code
67198 51151
Phone
+98 83 3826 5255
Fax
+98 83 3826 5255
Email
sdrc@kums.ac.ir
Web page address
https://sdrc.kums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Masoud Yousefi
Street address
Ghafari Aven.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Fax
+98 56 3238 1220
Email
research@bums.ac.ir
Web page address
https://rsh.bums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Seyed Mohammad Mousavi Mirzaei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Birjand University of Medical Sciences, Ghafari Avenue
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Phone
+98 56 3239 5000
Fax
Email
mousavim903@bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Seyed Mohammad Mousavi Mirzaei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Birjand University of Medical Sciences, Ghafari Avenue
City
Birjand
Province
South Khorasan
Postal code
9717853076
Phone
+98 56 3239 5000
Email
Kiani.za@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zahra Kiani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Saman 14
City
Birjand
Province
South Khorasan
Postal code
9717914898
Phone
009832341089
Fax
Email
Kiani.za@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available