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The effect of horse chestnut spray on sleep apnea

Investigating the effect of Aesculus hippocastanum intranasal spray on improving the symptoms of obstructive sleep apnea

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240526061903N1
Enrollment
90
Registered
2024-08-05
Start date
2024-06-20
Completion date
Unknown
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive sleep apnea. Obstructive sleep apnea (adult) (pediatric)

Interventions

Intervention 1: 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 ae

Sponsors

Birjand University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
11 Years to No maximum

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Changes in Beck Depression Inventory (BDI). Timepoint: before, 1 and 2 months after the intervention. Method of measurement: Beck Depression Inventory questionnaire.;Changes in Hamilton Anxiety Inventory (HRSA). Timepoint: before, 1 and 2 months after the intervention. Method of measurement: Hamilton Anxiety Inventory questionnaire.;Changes in Pittsburgh Sleep Quality Questionnaire (PSQI). Timepoint: before, 1 and 2 months after the intervention. Method of measurement: Pittsburgh Sleep Quality Questionnaire.;Quality of Life Questionnaire. Timepoint: before, 1 and 2 months after the intervention. Method of measurement: Quality of Life Questionnaire.;Insomnia and Daily Fatigue Severity Questionnaire. Timepoint: before, 1 and 2 months after the intervention. Method of measurement: Insomnia and Daily Fatigue Severity Questionnaire.;Brain Map, and EEG. Timepoint: before, 1 and 2 months after the intervention. Method of measurement: performing EEG and brain map.;Changes in Stop-Bang sleep apnea questionare. Timepoint: before, 1 and 2 months after the intervention. Method of measurement: Stop-Bang sleep apnea questionare.;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.;Changes in serum levels of CBC? ALT? AST? TSH? Bu? Cr? ESR ? CRP ?NF-?B? IL-6 IL 1 , TNF. Timepoint: before, 1 and 2 months after the intervention. Method of measurement: assay of serum level.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Mohammad Mousavi Mirzaei

Birjand University of Medical Sciences

mousavim903@bums.ac.ir+98 56 3239 5000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026