Efficiency of azelastine hydrochloride and fluticasone propionate nasal spray to improve PAP adherence in patients with obstructive sleep apnea

Phase 4

Completed

• Conditions: PAP adherence in patients with obstructive sleep apnea; Obstructive sleep apnea, PAP adherence, Intranasal corticosteroid, Continuous Positive Airway Pressure

• Registration Number: TCTR20220308003
• Lead Sponsor: Thammasat University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-08
• Study Completion: 2023-03-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

1. First time diagnosis of Obstrutive sleep apnea in Thammasat university hospital
2. Age beween 18 to 75 year
3. Willingness to volunteer to participate in the trial and sign yhe informed consent form

Exclusion Criteria

1. use of any intranasal corticosteroids during the last 3 months
2. any serious impair cognitive function or dementia or psychological disorder likely to preclude completion of the trial
3. any disease that have indication to use Intranasal corticosteroid
4. any other sleep disorder eg. Narcolepsy, Insomnia, Parasomnia, Central sleep apnea

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PAP adherence at 1 month after end of the intervention the percentage of days the CPAP device was used for more than or equal to 4 hours per day on CPAP device's data

Secondary Outcome Measures

Name	Time	Method
asal symptom at 1 month after end of the intervention Total nasal symptom score,Sleepiness at 1 month after end of the intervention Epworth Sleepiness Scale ,Quality of Life at 1 month after end of the intervention Rhinoconjunctivitis Quality of Life Questionnaire ,Nasal symptom at 1 month after end of the intervention Visual analog scale ,the number of hours per day the device was used (average hour/day used) at 1 month after end of the intervention CPAP device data,leakage value (95th percentile leakage) at 1 month after end of the intervention CPAP device data,the percentage number of days the CPAP device was used at 1 month after end of the intervention CPAP device data,AHI value after treatment at 1 month after end of the intervention CPAP device data,pressure below 15 cm H2O at 1 month after end of the intervention the percentage of days the CPAP device was used for more than or equal to 4 hours per day on CPAP device's data