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Completed

NCT Number: NCT05312723

Sleep Disturbance in Chronic Rhinitis

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.

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Key information

Conditions

Sleep Disturbance Airway Obstruction Disorders of Excessive Somnolence Dyssomnias Mental Disorders Nasal Obstruction Nervous System Diseases Nose Diseases Otorhinolaryngologic Diseases Parasomnias Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

RSUPN Dr. Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mean value of TNSS based on VAS symptoms

    Time frame: 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.

  2. Nasal obstruction symtpms evaluation (NOSE) score

    Time frame: 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.

  3. Sleep quality from Epworth sleepiness scale (ESS)

    Time frame: 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.

  4. Sleep quality from Pittsburg Sleep Quality Index (PSQI)

    Time frame: 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

  5. Objective sleep measurement using polysomnography (PSG)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 5, 2022
Registry last updated
Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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