Investigation of the effect of intranasal anti edema spray on patients with obstructive sleep apnea

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240526061903N3

Enrollment

100

Registered

2025-01-25

Start date

2025-01-18

Completion date

Unknown

Last updated

2025-02-03

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 acetazolamide 12.5 mg/ml every 8 hours for 45 days. Interv

Eligibility

Sex/Gender

All

Age

5 Years to 70 Years

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 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 History of liver and kidney diseases Pregnancy Breastfeeding Hypersensitivity to acetazolamide Metabolic acidosis Craniofacial anomaly Central apnea

Design outcomes

Primary

Measure	Time 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.;Changes in Stop-Bang sleep apnea questionare. Timepoint: Before, 1 and 2 months after the intervention. Method of measurement: Stop-Bang sleep apnea questionare.;Changes in serum levels of ALT? AST? TSH? Bun? Cr? CBC. Timepoint: Before, 1 and 2 months after the intervention. Method of measurement: Assay of serum level.	—

Measure

Time 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.;Changes in Stop-Bang sleep apnea questionare. Timepoint: Before, 1 and 2 months after the intervention. Method of measurement: Stop-Bang sleep apnea questionare.;Changes in serum levels of ALT? AST? TSH? Bun? Cr? CBC. Timepoint: Before, 1 and 2 months after the intervention. Method of measurement: Assay of serum level.

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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