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A Double Blind, Placebo Controlled Randomized Trial Evaluating the Effects of Fluticasone Nasal Spray in Subjects With Seasonal Allergic Rhinitis and a History of Sleep Disturbance on Cognitive Performance and Daytime Sleepiness
The hypothesis is that treating hay fever patients who had daytime sleepiness and slowed thinking because of the hay fever will improve when treated with an effective anti-hay fever medication, an intranasal steroid, that is will have less daytime sleepiness and demonstrate better thinking.
Details
| Lead sponsor | Western Sky Medical Research |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 40 |
| Start date | 2010-03 |
| Completion | 2010-10 |
Conditions
- Seasonal Allergic Rhinitis
Interventions
- Fluticasone furoate Nasal Spray 110 mcg
- Placebo
Primary outcomes
- Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance — over 2 weeks
The outcomes measures for TOVA are errors of omission. Targets which were not identified. Errors of commission are when targets are identified incorrectly. Reaction time is reported as the average time in milliseconds for the responses. The results are reported as mean and standard deviation as baseline and after 2 weeks of intervention. The difference between the means was evaluated by paired t testing. - Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Errors of Commission. — after 2 weeks intervention
The outcomes measures for TOVA are errors of commission. Targets which were identified incorrectly. Targets which are not identified, errors of omission and average time of each target viewing. - Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Response Time for Targets. — over 2 weeks
The outcomes measures for TOVA are the length of time to respond to targets. The time function represents the average time spent in milliseconds spent on each target.