Rhinitis, Sleep
Conditions
Keywords
Sleep, Pseudoephedrine
Brief summary
The hypothesis is that pseudoephedrine, a sympathomimetic amine commonly used as a decongestant, will decrease nasal congestion leading to increased patency of the nose and a decrease in nighttime sleep fragmentation in individuals with year round perennial allergic rhinitis (PAR). This decrease in sleep fragmentation will reduce daytime somnolence and fatigue.
Detailed description
The hypothesis is that pseudoephedrine, a sympathomimetic amine commonly used as a decongestant, will decrease nasal congestion leading to increased patency of the nose and a decrease in nighttime sleep fragmentation in individuals with year round perennial allergic rhinitis (PAR). This decrease in sleep fragmentation will reduce daytime somnolence and fatigue. We studied patients treated with placebo compared to FDA approved dose of pseudoephedrine and assessed sleep, QOL and daytime sleepiness.
Interventions
DRUGPseudoephedrine
Pseudoephedrine is a 240 mg PO per day
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 to 65. 2. History of allergic rhinitis. 3. The ability to be placed on placebo without significant compromise in the quality of life. 4. General good health. 5. Ability to comply with the protocol and sign an informed consent. 6. Have daytime sleepiness by history. 7. Have poor sleep by history. 8. Have fatigue by history. 9. Have a skin test or RAST test to a perennial allergen (indoor mold, dog, cat, mite) with correlating symptoms.
Exclusion criteria
1. Age fewer than 18 or over 65 years. 2. A history of sleep apnea. 3. Atopic diseases other than allergic rhinitis, such as atopic dermatitis or asthma. 4. Non-allergic rhinitis. 5. Hypertension 6. Diabetes Mellitus 7. Inability to tolerate pseudoephedrine 8. Significant other diseases as determined by the investigator. 9. Use of a research medication within 30 days. 10. Use of a nasal steroid or topical antihistamine or decongestant within 30 days. 11. Use of beta-blockers, antidepressants, oral decongestants, oral steroids, or H2-blockers. 12. Excessive use of alcohol or drug abuse. 13. Inability to stop medication use during run-in period. 14. Use of an oral antihistamine within 1 week of enrollment. 15. Failed to have benefit when pseudoephedrine was used for rhinitis or asthma in the past
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Sleep Associated With the Use of Pseudoephedrine as Compared to the Placebo | 3 years | sleep improvement by subjective questionnaires |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Daytime Somnolence With Pseudoephedrine as Compared to Placebo | 3 years | daytime sleepiness by subjective questionnaires |
Countries
United States
Participant flow
Pre-assignment details
data disposed of and no longer in existence
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo
Pseudoephedrine: Pseudoephedrine is a 240 mg PO per day | 0 |
| Pseudoephedrine Pseudoephedrine is a 240 mg PO per day
Pseudoephedrine: Pseudoephedrine is a 240 mg PO per day | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Improvement of Sleep Associated With the Use of Pseudoephedrine as Compared to the Placebo
sleep improvement by subjective questionnaires
Time frame: 3 years
Population: data disposed of and no longer in existence
Secondary
Improvement of Daytime Somnolence With Pseudoephedrine as Compared to Placebo
daytime sleepiness by subjective questionnaires
Time frame: 3 years
Population: data disposed of and no longer in existence