Obstructive Sleep ApneaBASETNCT05511974
BASET Scoring: A Novel Simple Biometric Score and Potential Tool for Diagnosis and Grading of Obstructive Sleep Apnea Syndrome (OSAS) Patients
A study testing BASET score in people with Obstructive Sleep Apnea, run by Mansoura University at 1 site in Egypt.
Trial summary
this study aims to assess the validity of BASET scoring as a new potential tool for diagnosis and grading the severity of OSAS patients and as screening of the risk factors of OSAS. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- BASET score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 5 Jul 2022
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All adult patients after having full night polysomnography.
Who cannot join
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BASET Scoring: A Novel Simple Biometric Score and Potential Tool for Diagnosis and Grading of Obstructive Sleep Apnea Syndrome Patients
this study aims to assess the validity of BASET scoring as a new potential tool for diagnosis and grading the severity of OSAS patients and as screening of the risk factors of OSAS.
Read the detailed description
The study will be conducted on one hundred twenty-six patients attending to sleep disorders breathing Unit, Chest Department at Mansoura University Hospital confirmed by polysomnography
- Conditions
- Obstructive Sleep Apnea
- Being tested
- BASET score
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BASET scoreDiagnostic test
The patients were divided into two groups. Group I (study group): consist of sixty-three patients having OSA. Group II (control group): consist of eighty-one non-OSA patients
| Study group | Role | What they receive |
|---|---|---|
| obstructive sleep apnea patients | Other | Group I : consist of sixty-three patients having OSA. Group II : consist of sixty-three non-OSA patients. Receives: Diagnostic Test: BASET score |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the performance of BASET score for diagnosis of OSAS
assess the performance of BASET score for diagnosis OSAS Region is neither concave nor dark red will take score (0). Region which is dark red but not concave will take score (1). Region which is concave but not dark red will take score (2). Region which is dark red and concave will take score (3).
Measured: up to 2 weeks.
grading of the severity of OSAS patients.
grading of the severity of OSAS patients. Region is neither concave nor dark red will take score (0). Region which is dark red but not concave will take score (1). Region which is concave but not dark red will take score (2). Region which is dark red and concave will take score (3).
Measured: up to one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Jan 2022
- Primary completion1 Jun 2022
- Study completion5 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira attia, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511974
- Sponsor's protocol ID
- R.22.06.1737
- Acronym
- BASET
- Status last verified
- Aug 2022
- First submitted
- 9 Aug 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study will be conducted on one hundred twenty-six patients attending to sleep disorders breathing Unit, Chest Department at Mansoura University Hospital confirmed by polysomnography. The patients will be divided into two groups: Group I (study group): consist of sixty-three patients having OSA. Group II (control group): consist of sixty-three non-OSA patients.
Publications
Saleh AM, Ahmed MA, El Said EA, Awadalla NJ, Attia AAMM. BASET scoring: A novel simple biometric score for screening and grading obstructive sleep apnea. Sleep Med X. 2023 Aug 14;6:100083. doi: 10.1016/j.sleepx.2023.100083. eCollection 2023 Dec 15.
PubMed 37635707
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BASET Scoring: A Novel Simple Biometric Score and Potential Tool for Diagnosis and Grading of Obstructive Sleep Apnea Syndrome Patients
- ClinicalTrials.gov ID
- NCT05511974
- Acronym / sponsor ID
- BASET / R.22.06.1737
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 23 Aug 2022 (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.
this study aims to assess the validity of BASET scoring as a new potential tool for diagnosis and grading the severity of OSAS patients and as screening of the risk factors of OSAS.
Detailed description
The study will be conducted on one hundred twenty-six patients attending to sleep disorders breathing Unit, Chest Department at Mansoura University Hospital confirmed by polysomnography
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obstructive sleep apnea patients | Other | Diagnostic Test: BASET scoreGroup I : consist of sixty-three patients having OSA. Group II : consist of sixty-three non-OSA patients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients after having full night polysomnography.
Key exclusion criteria (1 listed)
- Pregnant patients
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 |
|---|---|---|
| BASET scoreThe patients were divided into two groups. Group I (study group): consist of sixty-three patients having OSA. Group II (control group): consist of eighty-one non-OSA patients | Diagnostic test | obstructive sleep apnea patients |
Primary outcome
assess the performance of BASET score for diagnosis of OSAS
Time frame: up to 2 weeks.
assess the performance of BASET score for diagnosis OSAS Region is neither concave nor dark red will take score (0). Region which is dark red but not concave will take score (1). Region which is concave but not dark red will take score (2). Region which is dark red and concave will take score (3).
grading of the severity of OSAS patients.
Time frame: up to one week
grading of the severity of OSAS patients. Region is neither concave nor dark red will take score (0). Region which is dark red but not concave will take score (1). Region which is concave but not dark red will take score (2). Region which is dark red and concave will take score (3).
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 23 Aug 2022.
- Derived from this study: PubMed 37635707Saleh AM, Ahmed MA, El Said EA, Awadalla NJ, Attia AAMM. BASET scoring: A novel simple biometric score for screening and grading obstructive sleep apnea. Sleep Med X. 2023 Aug 14;6:100083. doi: 10.1016/j.sleepx.2023.100083. eCollection 2023 Dec 15.
- Individual participant dataSharing planned: No. The study will be conducted on one hundred twenty-six patients attending to sleep disorders breathing Unit, Chest Department at Mansoura University Hospital confirmed by polysomnography. The patients will be divided into two groups: Group I (study group): consist of sixty-three patients having OSA. Group II (control group): consist of sixty-three non-OSA patients.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
Sleep Apnea, Obstructive, Sleep Staging
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Enrolling by invitation
Myofunctional Therapy for Obstructive Sleep Apnea
Obstructive Sleep Apnea
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?
A study testing BASET score in people with Obstructive Sleep Apnea, run by Mansoura 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 1 inclusion and 1 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 23 Aug 2022. 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?
assess the performance of BASET score for diagnosis of OSAS (time frame: up to 2 weeks.). The study lists 2 primary outcomes in all. 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 NCT05511974, which also lists 1 linked publication.
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 23 Aug 2022.