COMPARATIVE EVALUATION OF OXYMETAZOLINE, XYLOMETAZOLINE, AND PLACEBO NASAL SPRAYS ON ODOR-SPECIFIC OLFACTORY PERCEPTION AND COGNITIVE FUNCTION IN HEALTHY ADULTS: A RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED CROSSOVER PILOT STUDY
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in odor identification scores across sprays and timepoints (olfactory test) and Changes in Stroop interference score and memory recall (5 word memory recall test and stroop test)
研究概览
简要总结
Although oxymetazoline and xylometazoline are widely used to relieve nasal congestion and improve airflow, the extent to which they enhance olfactory perception—and whether this translates into cognitive effects—remains unclear. Furthermore, there is no controlledcrossover study comparing these two decongestants directly on both smell and cognition in healthy adults. By directly comparing them against placebo and measuring cognitive and olfactory outcomes at targeted timepoints, this study bridges a vital gap by systematically evaluating whether standard ENT decongestants not only relieve nasal congestion but also modulate olfactory-driven neural circuits and thereby influence cognitive performance in real time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy human volunteers aged 18–35 years
- •Normosmic (normal sense of smell).
排除标准
- •Nasal disorders, allergies, chronic rhinitis, current smokers
- •Upper respiratory tract infection in the past 4 weeks
- •Neurological or psychiatric disorders
- •Cardiovascular disease or hypertension
- •Current use of decongestants or antihistamines.
结局指标
主要结局
Change in odor identification scores across sprays and timepoints (olfactory test) and Changes in Stroop interference score and memory recall (5 word memory recall test and stroop test)
时间窗: 0 minute(baseline), +5 minutes. +10 minutes, +30 minutes and +60 minutes followed by 48 hours washout period for each drug
次要结局
- Change in nasal patency (Visual Analogue Scale) and Comparison of onset and duration of effects(followed by 48 hours washout period for each drug)
研究者
Dr Charumathi P C
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES