BronchiectasisNCT07147803
Sleep Quality in Patients With Non-cystic Fibrosis Bronchiectasis
An observational study of Bronchiectasis and Sleep-Disordered Breathing, run by Assiut University at 1 site in Egypt.
Trial summary
Non-cystic fibrosis (non-CF) bronchiectasis is a chronic, heterogeneous airway disease characterized by irreversible bronchial dilatation, persistent airway infection, and neutrophilic inflammation that together drive daily cough, sputum production, recurrent exacerbations, and progressive functional decline. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis, Sleep-Disordered Breathing
- What is being tested?
- Pittsburgh Sleep Quality Index
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Oct 2025to 25 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Age ≥18 years (adults). * Confirmed stable non-CF bronchiectasis on high-resolution CT (HRCT) by a chest radiologist, with standard features (e.g., broncho-arterial ratio >1, lack of tapering, airways visible within 1 cm of pleura), documented in the medical record.
Who may be able to join
- Age ≥18 years (adults).
- Confirmed stable non-CF bronchiectasis on high-resolution CT (HRCT) by a chest radiologist, with standard features (e.g., broncho-arterial ratio >1, lack of tapering, airways visible within 1 cm of pleura), documented in the medical record.
- Non-cystic fibrosis etiology: no clinical diagnosis of cystic fibrosis; if prior doubt, a negative/normal sweat chloride or genetic report is required.
- Ability and willingness to participate in scheduled follow-up assessments at 3, 6, 9, and 12 months.
Who cannot join
- Acute bronchiectasis exacerbation at screening or within the preceding 4 weeks, including treatment with systemic antibiotics and/or systemic corticosteroids for respiratory deterioration during that period.
- Severe hemoptysis, unstable respiratory status, or any medical condition making completion of study questionnaires or scheduled assessments unsafe or unreliable in the investigator's judgment.
- Primary sleep disorders likely to substantially confound interpretation of sleep-quality measures, including newly diagnosed moderate-to-severe obstructive sleep apnea initiating positive airway pressure therapy, narcolepsy, or untreated restless legs syndrome; patients with previously diagnosed sleep disorders on stable treatment for ≥3 months may be included.
- Active pulmonary tuberculosis, interstitial lung disease, lung malignancy, pregnancy, or severe neurological or cognitive impairment that would prevent reliable completion of study assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep Quality in Patients With Non-cystic Fibrosis Bronchiectasis in Asyut University Hospitals: Correlation With Clinical, Functional, and Radiological Parameters
Non-cystic fibrosis (non-CF) bronchiectasis is a chronic, heterogeneous airway disease characterized by irreversible bronchial dilatation, persistent airway infection, and neutrophilic inflammation that together drive daily cough, sputum production, recurrent exacerbations, and progressive functional decline. Sleep is a key determinant of Health-Related Quality of Life (HRQoL) and cardiometabolic health. In chronic lung diseases, nocturnal hypoxemia, cough, dyspnea, and systemic inflammation commonly disrupt sleep continuity and architecture. In bronchiectasis specifically, several studies show high rates of poor sleep quality using the Pittsburgh Sleep Quality Index (PSQI), with ~50-60% of clinically stable patients classified as "poor sleepers," often accompanied by daytime dysfunction. Poor sleep correlates with disease severity indices and symptoms such as nocturnal cough.
Participants are assessed at baseline and followed at 3, 6, 9, and 12 months to evaluate changes in sleep quality over time and their relationships with changes in clinical status, functional measures, quality of life, and subsequent bronchiectasis-related outcomes.
Read the detailed description
In Egypt, bronchiectasis is a frequent clinical problem seen across tertiary hospitals. Recent tertiary-center studies from Upper Egypt (including Asyut) have described the prevalence and early outcomes of bronchiectasis among admitted adults, underscoring its local clinical significance. However, despite multiple Egyptian works on sleep quality in other respiratory conditions (e.g., COPD) using the PSQI, there remains a clear evidence gap regarding sleep quality specifically in adult non-CF bronchiectasis. International cohorts consistently demonstrate prevalent sleep disturbance in bronchiectasis and links to clinical severity, but Egyptian data in non-CF adult bronchiectasis are scarce. Locally contextualized evidence is needed to understand whether sleep impairment in our patients aligns with international observations and how it relates to spirometric function, structural disease burden, composite severity indices, and inflammatory biomarkers within an Upper Egypt setting.
Our study aims to Quantify sleep quality using the PSQI in adults with non-CF bronchiectasis attending Asyut University Hospitals, and Evaluate its correlations with clinical parameters (symptoms, exacerbations, mMRC, Quality of Life). Participants are also followed at 3, 6, 9, and 12 months to assess longitudinal changes in sleep quality and their relationships with changes in clinical and functional status, quality of life, and subsequent bronchiectasis-related outcomes.
- Conditions
- Bronchiectasis, Sleep-Disordered Breathing
- Being tested
- Pittsburgh Sleep Quality Index
- Keywords
- Bronchiectasis, Sleep, Quality of life, Exacerbations
- Medical subject headings
- Bronchiectasis, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pittsburgh Sleep Quality IndexOther
PSQI (Arabic validated version) - main sleep measure; global score 0-21; PSQI >5 = poor sleep quality; assessed at baseline and during scheduled follow-up visits.
| Study group | Role | What they receive |
|---|---|---|
| Bronchiectasis Patients | Confirmed non-CF bronchiectasis on high-resolution CT (HRCT) by a chest radiologist, with standard features (e.g., broncho-arterial ratio >1, lack of tapering, airways visible within 1 cm of pleura), documented in the medical record Receives: Other: Pittsburgh Sleep Quality Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of poor sleep quality
Assessment of the proportion of participants with poor sleep quality using the validated Arabic version of the Pittsburgh Sleep Quality Index (PSQI). The PSQI global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. Poor sleep quality is defined as a PSQI global score >5. Unit of measure: percentage of participants with PSQI >5.
Measured: Baseline
Secondary outcomes (14)
Change in Pittsburgh Sleep Quality Index Global Score From Baseline to Month 12
Assessment of change in PSQI global score from baseline through scheduled follow-up visits at Months 3, 6, 9, and 12. The PSQI global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. Unit of measure: PSQI score points.
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months.
Number of Bronchiectasis Exacerbations During 12-Month Follow-up
Assessment of the number of clinically documented bronchiectasis exacerbations occurring during follow-up. Exacerbation frequency will be recorded for each participant over the 12-month observation period. Unit of measure: number of exacerbations per participant.
Measured: Baseline to 12 months follow-up
Time to First Bronchiectasis Exacerbation
Assessment of time from baseline to the first clinically documented bronchiectasis exacerbation during follow-up. Longer time to first exacerbation indicates a longer exacerbation-free interval. Unit of measure: days.
Measured: Baseline to 12 months follow-up
Time to First Bronchiectasis-Related Hospital Admission
Assessment of time from baseline to the first hospital admission attributable to bronchiectasis exacerbation or respiratory deterioration during follow-up. Longer time to first bronchiectasis-related hospitalization indicates a longer hospitalization-free interval. Unit of measure: days.
Measured: Baseline to 12 months follow-up
Change in Forced Expiratory Volume in One Second Percent Predicted From Baseline to Month 12
Assessment of change in forced expiratory volume in one second percent predicted (FEV1% predicted) from baseline through Month 12. Greater preservation or improvement in FEV1% predicted indicates better pulmonary functional status. Unit of measure: percentage points.
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in Forced Vital Capacity Percent Predicted From Baseline to Month 12
Assessment of longitudinal change in forced vital capacity percent predicted (FVC% predicted). Greater preservation or improvement indicates better pulmonary functional status. Unit of measure: percentage points.
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in Modified Medical Research Council Dyspnea Score From Baseline to Month 12
Assessment of longitudinal change in dyspnea severity using the modified Medical Research Council (mMRC) scale. Scores range from 0 to 4, with higher scores indicating greater dyspnea-related functional limitation. Unit of measure: mMRC score points.
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months
Change in Cough Severity Visual Analogue Scale From Baseline to Month 12
Assessment of longitudinal change in cough severity using a 0-10 visual analogue scale. Higher scores indicate greater cough severity. Unit of measure: VAS score points.
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in Six-Minute Walk Distance From Baseline to Month 12
Assessment of longitudinal change in functional exercise capacity using the six-minute walk test. Greater walking distance indicates better exercise capacity. Unit of measure: meters.
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in Pittsburgh Sleep Quality Index Component Scores From Baseline to Month 12
Assessment of longitudinal change in the seven PSQI component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component ranges from 0 to 3, with higher scores indicating greater impairment. Unit of measure: PSQI component score points.
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in Resting Peripheral Oxygen Saturation From Baseline to Month 12
Assessment of longitudinal change in resting peripheral oxygen saturation measured by pulse oximetry during clinical stability. Higher values indicate better resting oxygenation. Unit of measure: percentage points.
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in Quality of Life-Bronchiectasis Domain Scores From Baseline to Month 12
Assessment of longitudinal change in Quality of Life-Bronchiectasis (QoL-B) domain scores during scheduled follow-up. QoL-B domains are scored from 0 to 100, with higher scores indicating better bronchiectasis-related health status and quality of life. Unit of measure: QoL-B domain score points.
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months.
Number of Bronchiectasis-Related Hospital Admissions During 12-Month Follow-up
Assessment of the number of hospital admissions attributable to bronchiectasis exacerbation or respiratory deterioration during follow-up. Unit of measure: number of hospital admissions per participant.
Measured: Baseline to 12 months follow-up.
Change in FEV1/FVC Ratio From Baseline to Month 12
Assessment of longitudinal change in the ratio of forced expiratory volume in one second to forced vital capacity (FEV1/FVC) during scheduled follow-up. Higher values generally indicate less airflow obstruction. Unit of measure: percentage points.
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start14 Oct 2025
- Primary completion15 May 2027 (estimated)
- Study completion25 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Montaser Gamal Ahmed, Assiut University
- Investigators
- Montaser Gamal, Lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147803
- Sponsor's protocol ID
- MGAhmed-Sleep-Bronchiectasis
- Status last verified
- Oct 2026
- First submitted
- 22 Aug 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gao Y, Guan W, Xu G, Lin Z, Tang Y, Lin Z, Li H, Gao Y, Luo Q, Zhong N, Chen R. Sleep disturbances and health-related quality of life in adults with steady-state bronchiectasis. PLoS One. 2014 Jul 18;9(7):e102970. doi: 10.1371/journal.pone.0102970. eCollection 2014.
PubMed 25036723Martinez-Garcia MA, Athanazio RA, Giron R, Maiz-Carro L, de la Rosa D, Olveira C, de Gracia J, Vendrell M, Prados-Sanchez C, Gramblicka G, Corso Pereira M, Lundgren FL, Fernandes De Figueiredo M, Arancibia F, Rached SZ. Predicting high risk of exacerbations in bronchiectasis: the E-FACED score. Int J Chron Obstruct Pulmon Dis. 2017 Jan 18;12:275-284. doi: 10.2147/COPD.S121943. eCollection 2017.
PubMed 28182132
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Quality in Patients With Non-cystic Fibrosis Bronchiectasis in Asyut University Hospitals: Correlation With Clinical, Functional, and Radiological Parameters
- ClinicalTrials.gov ID
- NCT07147803
- Acronym / sponsor ID
- MGAhmed-Sleep-Bronchiectasis
- Conditions
- Bronchiectasis, Sleep-Disordered Breathing
- Keywords
- Bronchiectasis, Sleep, Quality of life, Exacerbations
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 25 May 2027 (estimated)
- First posted
- 29 Aug 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.
Non-cystic fibrosis (non-CF) bronchiectasis is a chronic, heterogeneous airway disease characterized by irreversible bronchial dilatation, persistent airway infection, and neutrophilic inflammation that together drive daily cough, sputum production, recurrent exacerbations, and progressive functional decline. Sleep is a key determinant of Health-Related Quality of Life (HRQoL) and cardiometabolic health. In chronic lung diseases, nocturnal hypoxemia, cough, dyspnea, and systemic inflammation commonly disrupt sleep continuity and architecture. In bronchiectasis specifically, several studies show high rates of poor sleep quality using the Pittsburgh Sleep Quality Index (PSQI), with ~50-60% of clinically stable patients classified as "poor sleepers," often accompanied by daytime dysfunction. Poor sleep correlates with disease severity indices and symptoms such as nocturnal cough.
Participants are assessed at baseline and followed at 3, 6, 9, and 12 months to evaluate changes in sleep quality over time and their relationships with changes in clinical status, functional measures, quality of life, and subsequent bronchiectasis-related outcomes.
Detailed description
In Egypt, bronchiectasis is a frequent clinical problem seen across tertiary hospitals. Recent tertiary-center studies from Upper Egypt (including Asyut) have described the prevalence and early outcomes of bronchiectasis among admitted adults, underscoring its local clinical significance. However, despite multiple Egyptian works on sleep quality in other respiratory conditions (e.g., COPD) using the PSQI, there remains a clear evidence gap regarding sleep quality specifically in adult non-CF bronchiectasis. International cohorts consistently demonstrate prevalent sleep disturbance in bronchiectasis and links to clinical severity, but Egyptian data in non-CF adult bronchiectasis are scarce. Locally contextualized evidence is needed to understand whether sleep impairment in our patients aligns with international observations and how it relates to spirometric function, structural disease burden, composite severity indices, and inflammatory biomarkers within an Upper Egypt setting.
Our study aims to Quantify sleep quality using the PSQI in adults with non-CF bronchiectasis attending Asyut University Hospitals, and Evaluate its correlations with clinical parameters (symptoms, exacerbations, mMRC, Quality of Life). Participants are also followed at 3, 6, 9, and 12 months to assess longitudinal changes in sleep quality and their relationships with changes in clinical and functional status, quality of life, and subsequent bronchiectasis-related outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bronchiectasis Patients | – | Other: Pittsburgh Sleep Quality IndexConfirmed non-CF bronchiectasis on high-resolution CT (HRCT) by a chest radiologist, with standard features (e.g., broncho-arterial ratio >1, lack of tapering, airways visible within 1 cm of pleura), documented in the medical record |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Age ≥18 years (adults). * Confirmed stable non-CF bronchiectasis on high-resolution CT (HRCT) by a chest radiologist, with standard features (e.g., broncho-arterial ratio >1, lack of tapering, airways visible within 1 cm of pleura), documented in the medical record.
Key inclusion criteria (4 listed)
- Age ≥18 years (adults).
- Confirmed stable non-CF bronchiectasis on high-resolution CT (HRCT) by a chest radiologist, with standard features (e.g., broncho-arterial ratio >1, lack of tapering, airways visible within 1 cm of pleura), documented in the medical record.
- Non-cystic fibrosis etiology: no clinical diagnosis of cystic fibrosis; if prior doubt, a negative/normal sweat chloride or genetic report is required.
- Ability and willingness to participate in scheduled follow-up assessments at 3, 6, 9, and 12 months.
Key exclusion criteria (4 listed)
- Acute bronchiectasis exacerbation at screening or within the preceding 4 weeks, including treatment with systemic antibiotics and/or systemic corticosteroids for respiratory deterioration during that period.
- Severe hemoptysis, unstable respiratory status, or any medical condition making completion of study questionnaires or scheduled assessments unsafe or unreliable in the investigator's judgment.
- Primary sleep disorders likely to substantially confound interpretation of sleep-quality measures, including newly diagnosed moderate-to-severe obstructive sleep apnea initiating positive airway pressure therapy, narcolepsy, or untreated restless legs syndrome; patients with previously diagnosed sleep disorders on stable treatment for ≥3 months may be included.
- Active pulmonary tuberculosis, interstitial lung disease, lung malignancy, pregnancy, or severe neurological or cognitive impairment that would prevent reliable completion of study assessments.
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 |
|---|---|---|
| Pittsburgh Sleep Quality IndexPSQI (Arabic validated version) - main sleep measure; global score 0-21; PSQI >5 = poor sleep quality; assessed at baseline and during scheduled follow-up visits. | Other | Bronchiectasis Patients |
Primary outcome
Prevalence of poor sleep quality
Time frame: Baseline
Assessment of the proportion of participants with poor sleep quality using the validated Arabic version of the Pittsburgh Sleep Quality Index (PSQI). The PSQI global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. Poor sleep quality is defined as a PSQI global score >5. Unit of measure: percentage of participants with PSQI >5.
14 secondary outcomes
Change in Pittsburgh Sleep Quality Index Global Score From Baseline to Month 12
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Number of Bronchiectasis Exacerbations During 12-Month Follow-up
Time frame: Baseline to 12 months follow-up
Time to First Bronchiectasis Exacerbation
Time frame: Baseline to 12 months follow-up
Time to First Bronchiectasis-Related Hospital Admission
Time frame: Baseline to 12 months follow-up
Change in Forced Expiratory Volume in One Second Percent Predicted From Baseline to Month 12
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in Forced Vital Capacity Percent Predicted From Baseline to Month 12
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in Modified Medical Research Council Dyspnea Score From Baseline to Month 12
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
Change in Cough Severity Visual Analogue Scale From Baseline to Month 12
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in Six-Minute Walk Distance From Baseline to Month 12
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in Pittsburgh Sleep Quality Index Component Scores From Baseline to Month 12
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in Resting Peripheral Oxygen Saturation From Baseline to Month 12
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in Quality of Life-Bronchiectasis Domain Scores From Baseline to Month 12
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Number of Bronchiectasis-Related Hospital Admissions During 12-Month Follow-up
Time frame: Baseline to 12 months follow-up.
Change in FEV1/FVC Ratio From Baseline to Month 12
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 25036723Gao Y, Guan W, Xu G, Lin Z, Tang Y, Lin Z, Li H, Gao Y, Luo Q, Zhong N, Chen R. Sleep disturbances and health-related quality of life in adults with steady-state bronchiectasis. PLoS One. 2014 Jul 18;9(7):e102970. doi: 10.1371/journal.pone.0102970. eCollection 2014.
- Background: PubMed 28182132Martinez-Garcia MA, Athanazio RA, Giron R, Maiz-Carro L, de la Rosa D, Olveira C, de Gracia J, Vendrell M, Prados-Sanchez C, Gramblicka G, Corso Pereira M, Lundgren FL, Fernandes De Figueiredo M, Arancibia F, Rached SZ. Predicting high risk of exacerbations in bronchiectasis: the E-FACED score. Int J Chron Obstruct Pulmon Dis. 2017 Jan 18;12:275-284. doi: 10.2147/COPD.S121943. eCollection 2017.
- Individual participant dataSharing planned: No
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Bronchiectasis
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.
Montaser Gamal, Lecturer principal investigator
Assiut University
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 Bronchiectasis and Sleep-Disordered Breathing, run by Assiut 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Prevalence of poor sleep quality (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07147803, which also lists 2 linked publications.
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 27 Oct 2026.