Chronic RhinosinusitisSNOOZE-CRSNCT07242040
Sleep Disturbance and Daytime Fatigue as Predictors of Cognitive Decline and Functional Decline in Chronic Rhinosinusitis
An observational study of Chronic Rhinosinusitis and Sleep Disorders, run by Sinai University at 1 site in Egypt.
Trial summary
FOCUS-CRS is a cross-sectional observational study examining the relationship between sleep disturbance, daytime fatigue, and cognitive and functional health in patients with chronic rhinosinusitis (CRS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Rhinosinusitis, Sleep Disorders, Fatigue
- What is being tested?
- Self-Reported Questionnaires for Sleep, Fatigue, and Quality of Life
- How many people
- 134 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2024to 25 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study enrolled adult patients diagnosed with chronic rhinosinusitis (CRS), attending otolaryngology outpatient clinics at [insert institution name] during the study period. All participants met clinical diagnostic criteria for CRS as defined by current otolaryngologic guidelines (e.g., symptom duration ≥12 weeks, with or without radiologic confirmation). Eligible individuals were aged 18 years or older, capable of providing informed consent, and willing to complete standardized self-reported questionnaires related to sleep, fatigue, and quality of life. Patients with prior sinus surgery, neurological or psychiatric illness, or those on medications affecting sleep or cognition were excluded.
Who may be able to join
- Adults (≥18 years) diagnosed with CRS based on clinical guidelines
- Symptom duration ≥12 weeks
- Ability to provide informed consent
Who cannot join
- Prior sinus surgery
- Neurological or psychiatric disorders
- Use of sedatives or sleep-modulating medications
Trial locations and contacts
1 site in 1 country.
About this study
FOCUS-CRS is a cross-sectional observational study examining the relationship between sleep disturbance, daytime fatigue, and cognitive and functional health in patients with chronic rhinosinusitis (CRS). The study aims to determine whether self-reported sleep and fatigue scores predict impairments in physical and cognitive quality of life domains. A total of 134 adult CRS patients completed structured questionnaires assessing symptom burden and quality of life. Correlational and multivariate regression analyses were conducted to evaluate the predictive role of sleep disturbance and fatigue on functional and cognitive outcomes. This study seeks to improve understanding of underrecognized systemic effects of CRS, with implications for multidisciplinary patient care.
Read the detailed description
Background:
Chronic rhinosinusitis (CRS) is a prevalent inflammatory condition associated with significant impairment in quality of life. While sinonasal symptoms are well-documented, systemic manifestations such as sleep disturbance, fatigue, and cognitive decline are underexplored. Emerging evidence suggests that sleep and energy dysregulation may independently contribute to cognitive dysfunction and physical debilitation in chronic inflammatory diseases. However, limited research has quantified these associations specifically in CRS.
Objective:
The FOCUS-CRS study (Fatigue and cOgnitive Comorbidities of chrOnic rSinosUS) investigates whether sleep disturbance and daytime fatigue are significant predictors of cognitive and functional decline in adults with CRS. The study also explores the role of demographic and clinical factors such as age, gender, duration of symptoms, and comorbid conditions in moderating these relationships.
Methods:
This is a single-center, cross-sectional observational study involving 134 CRS patients recruited from outpatient clinics. Participants completed validated questionnaires measuring sleep disturbance, daytime fatigue, and domain-specific quality of life (QoL), including physical functioning (QoL-physical) and cognitive/mental health (QoL-mental). Spearman correlations and multivariate linear regression were performed to assess the predictive effects of sleep and fatigue scores on QoL outcomes, controlling for potential confounders.
Expected Impact:
The findings from this study will enhance clinical awareness of sleep and fatigue-related comorbidities in CRS and support the development of integrative care models. Early identification and management of sleep and fatigue symptoms may contribute to improved cognitive and functional outcomes in CRS patients.
- Conditions
- Chronic Rhinosinusitis, Sleep Disorders, Fatigue, Cognitive Dysfunction, Quality of Life Impairment
- Being tested
- Self-Reported Questionnaires for Sleep, Fatigue, and Quality of Life
- Keywords
- Quality of Life, Functional Decline, Cognitive Decline, Daytime Fatigue, Sleep Disturbance, Chronic Rhinosinusitis
- Medical subject headings
- Sleep Wake Disorders, Fatigue, Cognitive Dysfunction, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Reported Questionnaires for Sleep, Fatigue, and Quality of LifeDiagnostic test
Participants completed a set of validated self-report instruments to assess:
Sleep disturbance (Likert-type scale)
Daytime fatigue (Likert-type scale)
Quality of life - physical and mental domains
No clinical intervention was introduced. Data were analyzed using correlation and regression models to determine predictive associations.
| Study group | Role | What they receive |
|---|---|---|
| CRS Patients Group | All participants were adults diagnosed with chronic rhinosinusitis (CRS). This group underwent standardized, non-interventional assessments to evaluate the association between sleep disturbance, daytime fatigue, and quality of life outcomes. No experimental treatment or diagnostic procedures were administered as part of the study. Receives: Diagnostic Test: Self-Reported Questionnaires for Sleep, Fatigue, and Quality of Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life scale
The SF-36 Health Survey is a well-established instrument for measuring general health and quality of life. It evaluates eight domains of health, including both physical and mental aspects. Two summary scores are derived from these domains: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Physical Component Summary (PCS): Reflects physical health and functioning, including physical limitations and pain.
Mental Component Summary (MCS): Reflects emotional well-being, social functioning, and mental health status.
Measured: Day 1 (Single assessment at time of survey completion)
Secondary outcomes (1)
SNOT-22 Scale
The SNOT-22 is a widely used instrument to evaluate the impact of sinonasal conditions (e.g., chronic rhinosinusitis) on quality of life. It consists of 22 questions that assess symptoms and how these symptoms interfere with daily activities. The questions cover aspects such as nasal symptoms, sleep disturbance, and the impact on social functioning.
Measured: Day 1 (Single assessment at time of survey completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start15 Sep 2024
- Primary completion25 Sep 2025
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RhinosinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Gomaa Atiaa, Sinai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242040
- Sponsor's protocol ID
- SU.REC.2025(58H)
- Acronym
- SNOOZE-CRS
- Status last verified
- Nov 2025
- First submitted
- 26 Sep 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disturbance and Daytime Fatigue as Predictors of Cognitive Decline and Functional Decline in Chronic Rhinosinusitis
- ClinicalTrials.gov ID
- NCT07242040
- Acronym / sponsor ID
- SNOOZE-CRS / SU.REC.2025(58H)
- Conditions
- Chronic Rhinosinusitis, Sleep Disorders, Fatigue, Cognitive Dysfunction, Quality of Life Impairment
- Keywords
- Quality of Life, Functional Decline, Cognitive Decline, Daytime Fatigue, Sleep Disturbance, Chronic Rhinosinusitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Sinai UniversityUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
FOCUS-CRS is a cross-sectional observational study examining the relationship between sleep disturbance, daytime fatigue, and cognitive and functional health in patients with chronic rhinosinusitis (CRS). The study aims to determine whether self-reported sleep and fatigue scores predict impairments in physical and cognitive quality of life domains. A total of 134 adult CRS patients completed structured questionnaires assessing symptom burden and quality of life. Correlational and multivariate regression analyses were conducted to evaluate the predictive role of sleep disturbance and fatigue on functional and cognitive outcomes. This study seeks to improve understanding of underrecognized systemic effects of CRS, with implications for multidisciplinary patient care.
Detailed description
Background:
Chronic rhinosinusitis (CRS) is a prevalent inflammatory condition associated with significant impairment in quality of life. While sinonasal symptoms are well-documented, systemic manifestations such as sleep disturbance, fatigue, and cognitive decline are underexplored. Emerging evidence suggests that sleep and energy dysregulation may independently contribute to cognitive dysfunction and physical debilitation in chronic inflammatory diseases. However, limited research has quantified these associations specifically in CRS.
Objective:
The FOCUS-CRS study (Fatigue and cOgnitive Comorbidities of chrOnic rSinosUS) investigates whether sleep disturbance and daytime fatigue are significant predictors of cognitive and functional decline in adults with CRS. The study also explores the role of demographic and clinical factors such as age, gender, duration of symptoms, and comorbid conditions in moderating these relationships.
Methods:
This is a single-center, cross-sectional observational study involving 134 CRS patients recruited from outpatient clinics. Participants completed validated questionnaires measuring sleep disturbance, daytime fatigue, and domain-specific quality of life (QoL), including physical functioning (QoL-physical) and cognitive/mental health (QoL-mental). Spearman correlations and multivariate linear regression were performed to assess the predictive effects of sleep and fatigue scores on QoL outcomes, controlling for potential confounders.
Expected Impact:
The findings from this study will enhance clinical awareness of sleep and fatigue-related comorbidities in CRS and support the development of integrative care models. Early identification and management of sleep and fatigue symptoms may contribute to improved cognitive and functional outcomes in CRS patients.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRS Patients Group | – | Diagnostic Test: Self-Reported Questionnaires for Sleep, Fatigue, and Quality of LifeAll participants were adults diagnosed with chronic rhinosinusitis (CRS). This group underwent standardized, non-interventional assessments to evaluate the association between sleep disturbance, daytime fatigue, and quality of life outcomes. No experimental treatment or diagnostic procedures were administered as part of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study enrolled adult patients diagnosed with chronic rhinosinusitis (CRS), attending otolaryngology outpatient clinics at [insert institution name] during the study period. All participants met clinical diagnostic criteria for CRS as defined by current otolaryngologic guidelines (e.g., symptom duration ≥12 weeks, with or without radiologic confirmation). Eligible individuals were aged 18 years or older, capable of providing informed consent, and willing to complete standardized self-reported questionnaires related to sleep, fatigue, and quality of life. Patients with prior sinus surgery, neurological or psychiatric illness, or those on medications affecting sleep or cognition were excluded.
Key inclusion criteria (3 listed)
- Adults (≥18 years) diagnosed with CRS based on clinical guidelines
- Symptom duration ≥12 weeks
- Ability to provide informed consent
Key exclusion criteria (3 listed)
- Prior sinus surgery
- Neurological or psychiatric disorders
- Use of sedatives or sleep-modulating medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Reported Questionnaires for Sleep, Fatigue, and Quality of LifeParticipants completed a set of validated self-report instruments to assess: Sleep disturbance (Likert-type scale) Daytime fatigue (Likert-type scale) Quality of life - physical and mental domains No clinical intervention was introduced. Data were analyzed using correlation and regression models to determine predictive associations. | Diagnostic test | CRS Patients Group |
Primary outcome
Quality of life scale
Time frame: Day 1 (Single assessment at time of survey completion)
The SF-36 Health Survey is a well-established instrument for measuring general health and quality of life. It evaluates eight domains of health, including both physical and mental aspects. Two summary scores are derived from these domains: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Physical Component Summary (PCS): Reflects physical health and functioning, including physical limitations and pain. Mental Component Summary (MCS): Reflects emotional well-being, social functioning, and mental health status.
1 secondary outcome
SNOT-22 Scale
Time frame: Day 1 (Single assessment at time of survey completion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Rhinosinusitis and Sleep Disorders, run by Sinai University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life scale (time frame: Day 1 (Single assessment at time of survey completion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.