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The effect of intranasal spray on sleep apnea

Investigating the effect of intranasal spray with anti-edema and anti-inflammatory effect on improving the symptoms of obstructive sleep apnea

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240526061903N2
Enrollment
100
Registered
2024-09-08
Start date
2024-08-22
Completion date
Unknown
Last updated
2024-09-16

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 (pilot study): Patients suffering from obstructive sleep apnea receive three puffs in each nostril of a spray containing 10 mg/ml furosemide every 8 hours for 30 d

Sponsors

Birjand University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 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 obstructive apneas greater than five 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 5 years Having cardiac pace maker Hypersensitivity to any drugs Substance abuse History of liver and kidney diseases Having dementia symptoms History of hypokalemia

Design outcomes

Primary

MeasureTime frame
Changes in Beck Depression Inventory (BDI). Timepoint: Before, after 45 days of interventions. Method of measurement: Beck Depression Inventory questionnaire.;Changes in Hamilton Anxiety Inventory (HRSA). Timepoint: Before, after 45 days of interventions. Method of measurement: Hamilton Anxiety Inventory questionnaire.;Changes in Pittsburgh Sleep Quality Questionnaire (PSQI). Timepoint: Before, after 45 days of interventions. Method of measurement: Pittsburgh Sleep Quality Questionnaire.;Quality of Life Questionnaire. Timepoint: Before, after 45 days of interventions. Method of measurement: Quality of Life Questionnaire.;Changes in Stop-Bang sleep apnea questionnaire. Timepoint: Before, after 45 days of interventions. Method of measurement: Stop-Bang sleep apnea questionnaire.;Determining the number of apnea and hypopnea and changes in heart rate and oxygen saturation. Timepoint: Before, after 45 days of interventions. Method of measurement: Determining by using Polysomnography.;Changes in serum levels of CBC? ALT? AST? TSH? Bun? Cr. Timepoint: Before, after 45 days of interventions. 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