Sleep Disturbance in Chronic Rhinitis

NCT05312723 | Completed

• 1 other identifier: 20-01-0074
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disturbance

Keywords

allergic; nasal congestion; daytime sleepiness; polysomnography

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Rhinitis allergy

Patients with rhinitis symptoms and positive skin pric test to one or more allergens.

Non-rhinitis allergy

Patients with rhinitis symptoms and negative skin pric test to one or more allergens.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Allergic and non-allergic rhinitis patients

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

RSUPN Dr. Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Parasomnias; Nasal Obstruction; Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Nina Irawati

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Allergy Immunology Division, Otorhinolaryngology Head and Neck Surgery Department

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 5, 2022
• Study Start: March 15, 2020
• Primary Completion: August 15, 2020
• Study Completion: August 15, 2020
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

ID (1)