An observational study in Sleep Disturbance, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-04-14.
Sponsored by Indonesia University · Observational
The aim of this study is to evaluate the characteristic of sleep disturbance in allergic and non-allergic rhinitis in Dr. Cipto Mangunkusumo Hospital, Jakarta. A cross sectional analytic descriptive study with consecutive sampling was performed. A total of 22 chronic rhinitis patients, consisted of 11 allergic and 11 non-allergic rhinitis were evaluated of their sleep disturbance's characteristics.
At first, all recruited subjects were evaluated for total nasal symptom scores (TNSS) and nasal obstruction symptoms evaluation scores (NOSE). Sleep disorder was assessed using Epworth Sleepiness Scale (ESS), Pittsburg Sleep Quality Index (PSQI) questionnaires, and polysomnography (PSG). Both the allergic and non-allergic rhinitis groups will be compared in terms of their sleep disturbance characteristics (from comparing ESS, PSQI, and PSG results).
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 22 is below the median of 141 across 172 observational studies indexed under Rhinitis.
Browse Rhinitis studies →Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.
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Allergic and non-allergic rhinitis patients
Exclusion Criteria:
Patients with rhinitis symptoms and positive skin pric test to one or more allergens.
Patients with rhinitis symptoms and negative skin pric test to one or more allergens.
Mean value of TNSS based on VAS symptoms
Clinical symptoms was evaluated by visual analogue scale (VAS) based on total nasal symptoms score (TNSS). Total nasal symptoms score are based on four symptoms, which are rhinorrea, sneezing, itchy nose, and nose obstruction. Each symptom will be given a score between 1 (most mild symptom) until 5 (most severe symptom). The minum score for VAS based on TNSS is 4 (most mild symptom) and the maximum score is 40 (most severe symptom). VAS score less than five indicates a controlled rhinitis symptoms, while ≥ 5 indicates that symptoms are not controlled.
Time frame: Evaluation is done at Day 1(cross-sectional)
Nasal obstruction symtpms evaluation (NOSE) score
Nasal obstruction symptoms was evaluated by NOSE score. It evaluates 5 items that indicates nasal obstruction symptoms that was experienced in the past 1 month. Each item has a score range from 0 to 20. It has a minimum score of 0 and a maximum score of 100. Score 5-25 indicates mild nasal obstruction, score 30-50 indicates moderate nasal obstruction, score 55-75 indicates severe nasal obstruction, and score \> 80 indicates extreme nasal obstruction.
Time frame: Evaluation is done at Day 1 (cross-sectional)
Sleep quality from Epworth sleepiness scale (ESS)
Sleep quality assessed by Epworth sleepiness scale. ESS is a self-administered questionnaire consisted of 8 questions. It assessed the chances of falling asleep while engaged in different activities. Each item scored 0-3, with a minimum score of 0 (low normal daytime sleepiness) and a maximum score of 24 (severe daytime sleepiness). In this study, the cut off is score 5-9 indicates mild daytime sleepiness and score \> 10 indicates severe daytime sleepiness.
Time frame: Evaluation is done at Day 1 (cross-sectional)
Sleep quality from Pittsburg Sleep Quality Index (PSQI)
Sleep quality assessed by Pittsburg Sleep Quality Index. PSQI consisted of 10 questions. These 10 questions were divided to 7 components, including subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction. Each component score range from 0-23. Total score can range from 0 to 21. Score \< 5 indicates good sleep quality and \> 5 indicates poor sleep quality
Time frame: Evaluation is done at Day 1 (cross-sectional)
Objective sleep measurement using polysomnography (PSG)
Sleep parameters were objectively measured using polysomnography (PSG). Sleep architecture was assessed using non-rapid eye movement (NREM)/ rapid eye movement (REM) and respiratory analysis was assessed using respiratory disturbance index - rapid eye movement (RDI-REM) and respiratory effort related arousals (RERA). All the parameters will be presented as numeric data.
Time frame: Evaluation is done at Day 1 (cross-sectional)
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Indonesia University