Sleep Disturbance in Chronic Rhinitis

Sleep Disturbance Clinical Trial

Official title:

Sleep Disturbance in Chronic Rhinitis: Evaluation of Nasal Symptoms, Sleep Disorder Questionnaires, and Sleep Architecture in Allergic & Non-Allergic Rhinitis in Dr. Cipto Mangunkusumo Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05312723
• Other study ID #: 20-01-0074
• Status: Completed
• Start date: March 15, 2020
• Est. completion date: August 15, 2020

Study information

• Verified date: April 2022
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 15, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Rhinitis
• Sleep Disturbance

Locations

Country	Name	City	State
Indonesia	RSUPN Dr. Cipto Mangunkusumo	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Evaluation is done at Day 1(cross-sectional)
Primary	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.	Evaluation is done at Day 1 (cross-sectional)
Primary	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.	Evaluation is done at Day 1 (cross-sectional)
Primary	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	Evaluation is done at Day 1 (cross-sectional)
Primary	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.	Evaluation is done at Day 1 (cross-sectional)