SILENT SINUS SYNDROMENCT04388345
SILENT SINUS SYNDROME (First Case Report, Saudi Arabia With Recommendation)
An observational study of SILENT SINUS SYNDROME, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
Silent sinus syndrome is a rare disorder that presents a diagnostic challenge, most of the patients with this syndrome present with ophthalmological complaints without any nasal sinus symptoms, and it has a painless course and slow development. Read more about this study
- Who is it for?
- Ages 37 to 37 years, women only
- Conditions the study is for
- SILENT SINUS SYNDROME
- How many people
- 1 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Mar 2019to 30 Apr 2020
- 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 37 to 37 years
- Women only
- Adult
Study population: community sample
Who may be able to join
- signs or symptoms in the eyes. signs in the Sinus that seen by X-ray.
Who cannot join
- Children ( <7 years old)
Trial locations and contacts
1 site in 1 country.
About this study
Silent sinus syndrome is a rare disorder that presents a diagnostic challenge, most of the patients with this syndrome present with ophthalmological complaints without any nasal sinus symptoms, and it has a painless course and slow development. A case report of a 37-years-old-female who was complaining of severe throbbing pain since 2009, is presented here where the diagnosis of SSS was obtained in 2018, this delay in diagnosing the situation had affected the patient lifestyle tremendously.
Read the detailed description
Silent sinus syndrome is a rare disorder that presents a diagnostic challenge, most of the patients with this syndrome present with ophthalmological complaints without any nasal sinus symptoms, and it has a painless course and slow development. The syndrome can be diagnosed clinically and confirmed radiologically, and CT imaging is considered the gold standard for its diagnosis. The classical radiographic findings are opacification and collapse of the sinus walls. Functional endoscopic sinus surgery (FESS) is the standard gold treatment of choice to arrest the progression of the disease.
A case report of a 37-years-old-female who was complaining of severe throbbing pain since 2009, is presented here where the diagnosis of SSS was obtained in 2018, this delay in diagnosing the situation had affected the patient lifestyle tremendously.
Accordingly, knowledge of the signs and features of SSS can result in an accurate diagnosis. Suspected cases of silent sinus syndrome require prompt ear, nose, and throat referral for consideration of definitive diagnosis and surgical management. Nasal endoscopy and clinical evaluation are also essential for the diagnosis. Our recommendation is to consider SSS as a differential diagnosis for patients with spontaneous enophthalmos and hypoglobus, even in the absence of maxillary sinus opacification. Moreover, encourage all the specialists in the medical and the dental field to communicate well together in cases like this.
- Conditions
- SILENT SINUS SYNDROME
- Keywords
- Case report, Silent sinus syndrome, SSS, CT, MRI, Functional endoscopic sinus surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of the signs and features of Silent Sinus Syndeome will result in accurate diagnosis by A computerized tomography (CT) scan.
Suspected cases of silent sinus syndrome require prompt ear, nose and throat referral for consideration of definitive diagnosis and surgical management. Nasal endoscopy and clinical evaluation are essential for the diagnosis, while CT imaging consider the gold standard for its diagnosis. Functional endoscopic sinus surgery is the gold standard treatment to arrest the progression of the disease and the position of the orbital floor can improve following surgical treatment.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start1 Mar 2019
- Primary completion25 Oct 2019
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for SILENT SINUS SYNDROMEStudies 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
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouf Saloom Alsaloom, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388345
- Sponsor's protocol ID
- 434200641
- Status last verified
- May 2020
- First submitted
- 11 May 2020
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cobb AR, Murthy R, Cousin GC, El-Rasheed A, Toma A, Uddin J, Manisali M. Silent sinus syndrome. Br J Oral Maxillofac Surg. 2012 Sep;50(6):e81-5. doi: 10.1016/j.bjoms.2011.10.001. Epub 2011 Nov 1.
PubMed 22051178Bossolesi P, Autelitano L, Brusati R, Castelnuovo P. The silent sinus syndrome: diagnosis and surgical treatment. Rhinology. 2008 Dec;46(4):308-16.
PubMed 19146002Guillen DE, Pinargote PM, Guarderas JC. The silent sinus syndrome: protean manifestations of a rare upper respiratory disorder revisited. Clin Mol Allergy. 2013 Dec 9;11(1):5. doi: 10.1186/1476-7961-11-5.
PubMed 24321328Hourany R, Aygun N, Della Santina CC, Zinreich SJ. Silent sinus syndrome: an acquired condition. AJNR Am J Neuroradiol. 2005 Oct;26(9):2390-2.
PubMed 16219851Soparkar CN, Patrinely JR, Cuaycong MJ, Dailey RA, Kersten RC, Rubin PA, Linberg JV, Howard GR, Donovan DT, Matoba AY, et al. The silent sinus syndrome. A cause of spontaneous enophthalmos. Ophthalmology. 1994 Apr;101(4):772-8. doi: 10.1016/s0161-6420(94)31267-x.
PubMed 8152774Vahdani K, Rose GE. Bilateral Silent Sinus (Imploding Antrum) Syndrome. Ophthalmic Plast Reconstr Surg. 2019 May/Jun;35(3):e67-e69. doi: 10.1097/IOP.0000000000001350.
PubMed 30844910Babar-Craig H, Kayhanian H, De Silva DJ, Rose GE, Lund VJ. Spontaneous silent sinus syndrome (imploding antrum syndrome): case series of 16 patients. Rhinology. 2011 Aug;49(3):315-7. doi: 10.4193/Rhino10.103.
PubMed 21858262Tribich S, Mahoney CJ, Davies NW. Silent sinus syndrome: an unusual case of facial numbness. Pract Neurol. 2018 Dec;18(6):494-496. doi: 10.1136/practneurol-2017-001807. Epub 2018 Jul 20.
PubMed 30030411Numa WA, Desai U, Gold DR, Heher KL, Annino DJ. Silent sinus syndrome: a case presentation and comprehensive review of all 84 reported cases. Ann Otol Rhinol Laryngol. 2005 Sep;114(9):688-94. doi: 10.1177/000348940511400906.
PubMed 16240931Suh JD, Ramakrishnan V, Lee JY, Chiu AG. Bilateral silent sinus syndrome. Ear Nose Throat J. 2012 Dec;91(12):E19-21. doi: 10.1177/014556131209101217.
PubMed 23288826
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SILENT SINUS SYNDROME (First Case Report, Saudi Arabia With Recommendation)
- ClinicalTrials.gov ID
- NCT04388345
- Acronym / sponsor ID
- 434200641
- Conditions
- SILENT SINUS SYNDROME
- Keywords
- Case report, Silent sinus syndrome, SSS, CT, MRI, Functional endoscopic sinus surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 25 Oct 2019 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 14 May 2020 (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.
Silent sinus syndrome is a rare disorder that presents a diagnostic challenge, most of the patients with this syndrome present with ophthalmological complaints without any nasal sinus symptoms, and it has a painless course and slow development. A case report of a 37-years-old-female who was complaining of severe throbbing pain since 2009, is presented here where the diagnosis of SSS was obtained in 2018, this delay in diagnosing the situation had affected the patient lifestyle tremendously.
Detailed description
Silent sinus syndrome is a rare disorder that presents a diagnostic challenge, most of the patients with this syndrome present with ophthalmological complaints without any nasal sinus symptoms, and it has a painless course and slow development. The syndrome can be diagnosed clinically and confirmed radiologically, and CT imaging is considered the gold standard for its diagnosis. The classical radiographic findings are opacification and collapse of the sinus walls. Functional endoscopic sinus surgery (FESS) is the standard gold treatment of choice to arrest the progression of the disease.
A case report of a 37-years-old-female who was complaining of severe throbbing pain since 2009, is presented here where the diagnosis of SSS was obtained in 2018, this delay in diagnosing the situation had affected the patient lifestyle tremendously.
Accordingly, knowledge of the signs and features of SSS can result in an accurate diagnosis. Suspected cases of silent sinus syndrome require prompt ear, nose, and throat referral for consideration of definitive diagnosis and surgical management. Nasal endoscopy and clinical evaluation are also essential for the diagnosis. Our recommendation is to consider SSS as a differential diagnosis for patients with spontaneous enophthalmos and hypoglobus, even in the absence of maxillary sinus opacification. Moreover, encourage all the specialists in the medical and the dental field to communicate well together in cases like this.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 37 to 37 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- community sample
Key inclusion criteria (1 listed)
- signs or symptoms in the eyes. signs in the Sinus that seen by X-ray.
Key exclusion criteria (1 listed)
- Children ( <7 years old)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Knowledge of the signs and features of Silent Sinus Syndeome will result in accurate diagnosis by A computerized tomography (CT) scan.
Time frame: 10 years
Suspected cases of silent sinus syndrome require prompt ear, nose and throat referral for consideration of definitive diagnosis and surgical management. Nasal endoscopy and clinical evaluation are essential for the diagnosis, while CT imaging consider the gold standard for its diagnosis. Functional endoscopic sinus surgery is the gold standard treatment to arrest the progression of the disease and the position of the orbital floor can improve following surgical treatment.
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 14 May 2020.
- Background: PubMed 22051178Cobb AR, Murthy R, Cousin GC, El-Rasheed A, Toma A, Uddin J, Manisali M. Silent sinus syndrome. Br J Oral Maxillofac Surg. 2012 Sep;50(6):e81-5. doi: 10.1016/j.bjoms.2011.10.001. Epub 2011 Nov 1.
- Background: PubMed 19146002Bossolesi P, Autelitano L, Brusati R, Castelnuovo P. The silent sinus syndrome: diagnosis and surgical treatment. Rhinology. 2008 Dec;46(4):308-16.
- Background: PubMed 24321328Guillen DE, Pinargote PM, Guarderas JC. The silent sinus syndrome: protean manifestations of a rare upper respiratory disorder revisited. Clin Mol Allergy. 2013 Dec 9;11(1):5. doi: 10.1186/1476-7961-11-5.
- Background: PubMed 16219851Hourany R, Aygun N, Della Santina CC, Zinreich SJ. Silent sinus syndrome: an acquired condition. AJNR Am J Neuroradiol. 2005 Oct;26(9):2390-2.
- Background: PubMed 8152774Soparkar CN, Patrinely JR, Cuaycong MJ, Dailey RA, Kersten RC, Rubin PA, Linberg JV, Howard GR, Donovan DT, Matoba AY, et al. The silent sinus syndrome. A cause of spontaneous enophthalmos. Ophthalmology. 1994 Apr;101(4):772-8. doi: 10.1016/s0161-6420(94)31267-x.
- Background: PubMed 30844910Vahdani K, Rose GE. Bilateral Silent Sinus (Imploding Antrum) Syndrome. Ophthalmic Plast Reconstr Surg. 2019 May/Jun;35(3):e67-e69. doi: 10.1097/IOP.0000000000001350.
- Background: PubMed 21858262Babar-Craig H, Kayhanian H, De Silva DJ, Rose GE, Lund VJ. Spontaneous silent sinus syndrome (imploding antrum syndrome): case series of 16 patients. Rhinology. 2011 Aug;49(3):315-7. doi: 10.4193/Rhino10.103.
- Background: PubMed 30030411Tribich S, Mahoney CJ, Davies NW. Silent sinus syndrome: an unusual case of facial numbness. Pract Neurol. 2018 Dec;18(6):494-496. doi: 10.1136/practneurol-2017-001807. Epub 2018 Jul 20.
- Background: PubMed 16240931Numa WA, Desai U, Gold DR, Heher KL, Annino DJ. Silent sinus syndrome: a case presentation and comprehensive review of all 84 reported cases. Ann Otol Rhinol Laryngol. 2005 Sep;114(9):688-94. doi: 10.1177/000348940511400906.
- Background: PubMed 23288826Suh JD, Ramakrishnan V, Lee JY, Chiu AG. Bilateral silent sinus syndrome. Ear Nose Throat J. 2012 Dec;91(12):E19-21. doi: 10.1177/014556131209101217.
- Individual participant dataSharing planned: Undecided
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 SILENT SINUS SYNDROME, run by King Saud University at 1 site in Saudi Arabia.
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 14 May 2020. 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 Saudi Arabia. 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?
Knowledge of the signs and features of Silent Sinus Syndeome will result in accurate diagnosis by A computerized tomography (CT) scan. (time frame: 10 years). 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 NCT04388345, which also lists 10 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 14 May 2020; AzTrials last refreshed its copy on 6 Nov 2026.