Sleep Disturbance in Chronic Rhinitis

Completed

• Conditions: Sleep Disturbance

• Registration Number: NCT05312723
• Lead Sponsor: Indonesia University

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2020-03-15
• Primary Completion: 2020-08-15
• Study Completion: 2020-08-15
• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-03-28
• Status Verified: 2022-04
• Study First Posted: 2022-04-05
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• All male and female between 18-60 years old with chronic rhinitis symptoms and sleep disorder
• Did not receive intranasal steroid within the last one month
• Have psychiatric disorder

Exclusion Criteria

• Polyp
• Nasal or sinonasal tumor
• Septum deviation
• Chronic rhinosinusitis
• Adenoid hypertrophy
• Tonsil hypertrophy
• Macroglossia
• Oropharyngeal tumor

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nasal obstruction symtpms evaluation (NOSE) score	Evaluation is done at Day 1 (cross-sectional)	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.
Sleep quality from Epworth sleepiness scale (ESS)	Evaluation is done at Day 1 (cross-sectional)	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.
Objective sleep measurement using polysomnography (PSG)	Evaluation is done at Day 1 (cross-sectional)	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.
Mean value of TNSS based on VAS symptoms	Evaluation is done at Day 1(cross-sectional)	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.
Sleep quality from Pittsburg Sleep Quality Index (PSQI)	Evaluation is done at Day 1 (cross-sectional)	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

Trial Locations

Locations (1)

RSUPN Dr. Cipto Mangunkusumo; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia