Obstructive Sleep Apnea SyndromeNCT05206916
New Procedures in Treating Patients With Obstructive Sleep Apnea Syndrome
A study testing cryotherapy in people with Obstructive Sleep Apnea Syndrome, run by Sohag University.
Trial summary
Drug-induced sleep endoscopy (DISE) used as diagnostic tool but not yet as a therapeutic procedures to manage the upper airway of snorers and obstructive sleep apnea patients in conditions that mimic natural sleep, there are many aspects that need to be standardized in order to obtain reliable and reproducible… Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- cryotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- May 2022to Sep 2023
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 25 - 65 years.
- Diagnosed with mild, moderate to severe OSA based American Acadmey of Sleep Medicine (AASM) severity Index of apnea hypopnea index (AHI) after Polysomnography (AHI ≥ 5-15 mild, ≥15-30 moderate, ≥30 severe) based on a prior sleep study.
- BMI is between 28 kg/m2 and 40 kg/m2 at enrollment.
- Negative result for COVID-19 polymerase chain reaction (RT-PCR) test and absence of clinical symptoms for COVID-19.
Who cannot join
- Subjects with a high percentage of central apneas suggesting heart failure.
- Contraindication to general anesthesia or surgery.
- Craniofacial abnormality (e.g. retrognathia, micrognathia, etc.) thought to be the primary cause of OSA.
- Obvious fixed upper airway obstructions (tumors, polyps, nasal obstruction).
- Tonsil size ≥ +3.
- Previous surgery within 12 weeks of scheduled procedure performed on the soft tissue of the upper airway (e.g., uvula, soft palate or tonsils).
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- Oral cancer or non-healing oral wounds.
- Presence of symptoms of influenza-like symptoms.
- History of surgery affecting the tongue [transoral robotic surgery (TORS), semi-glossectomy, radio-frequency ablation of base of tongue (RFBOT), maxillomandibular advancement (MMA), hypoglossal nerve stimulation (HGNS)].
- History of radiation therapy to neck or upper respiratory tract
- Surgical resection for cancer or congenital malformations in the larynx, tongue, or throat (with exception of tonsillectomy and/or adenoidectomy).
- Clinical evidence of severe chronic obstructive or restrictive pulmonary disease (for example chronic bronchitis, emphysema, pulmonary fibrosis).
- Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism).
- Currently receiving treatment for severe cardiac valvular dysfunction, new york heart association (NYHA) Class III or IV heart failure, unstable angina or recent (< 12 month) myocardial infarction or severe cardiac arrhythmias.
- Subjects with bleeding event, known bleeding diathesis, impaired immunity for any reason, or heart attack or stroke within the last 12 months.
- Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or expected to institute dialysis within 12 months.
- History or current clinical evidence of transient ischaemic attack (TIA) or stroke or muscular dysfunction.
- Taking medications that in the opinion of the consulting physician may alter consciousness, the pattern of respiration, or sleep architecture, such examples being benzodiazepines, opiates, neuroleptics, prescription stimulants, phenothiazine, or any form of chemical substance abuse.
- History of dementia or active psychiatric disease that may impact study compliance.
- Females who are pregnant or females of childbearing age with intention to become pregnant during the study period (≤ 3 months from treatment date).
- Unable and/or unwilling to comply with study requirements or to provide written informed consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Novel Drug Induced Sleep Endoscopy Procedures in Treating Patients With Obstructive Sleep Apnea Syndrome
Drug-induced sleep endoscopy (DISE) used as diagnostic tool but not yet as a therapeutic procedures to manage the upper airway of snorers and obstructive sleep apnea patients in conditions that mimic natural sleep, there are many aspects that need to be standardized in order to obtain reliable and reproducible information result in cryotherapy at sites of vibration as origin of snoring and site of collapse.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- cryotherapy
- 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.
cryotherapyProcedure or surgery
Cryotherapy at sites of vibration as origin of snoring and site of collapse for patients with obstructive sleep apnea syndrome
| Study group | Role | What they receive |
|---|---|---|
| evaluation of cryotherapy as treatment for obstructive sleep apnea patients | Other | Not described Receives: Procedure: cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
value, side effect and impact of cryotherapy in treatment of patients with obstructive sleep apnea syndrome
we use drug induced sleep endoscopy during intervention and use polysomnography before the intervention as diagnostic for cases and after intervention for follow up of cases
Measured: polysomnography will done after 2 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study startMay 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University
- Responsible party
- Principal investigator, Fatma hassanien mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206916
- Sponsor's protocol ID
- Soh-Med-21-12-22
- Status last verified
- Jan 2022
- First submitted
- 12 Jan 2022
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Novel Drug Induced Sleep Endoscopy Procedures in Treating Patients With Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT05206916
- Acronym / sponsor ID
- Soh-Med-21-12-22
- Conditions
- Obstructive Sleep Apnea Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Collaborators
- Mansoura University
- Study start
- May 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 25 Jan 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.
Drug-induced sleep endoscopy (DISE) used as diagnostic tool but not yet as a therapeutic procedures to manage the upper airway of snorers and obstructive sleep apnea patients in conditions that mimic natural sleep, there are many aspects that need to be standardized in order to obtain reliable and reproducible information result in cryotherapy at sites of vibration as origin of snoring and site of collapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| evaluation of cryotherapy as treatment for obstructive sleep apnea patients | Other | Procedure: cryotherapy |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 25 - 65 years.
- Diagnosed with mild, moderate to severe OSA based American Acadmey of Sleep Medicine (AASM) severity Index of apnea hypopnea index (AHI) after Polysomnography (AHI ≥ 5-15 mild, ≥15-30 moderate, ≥30 severe) based on a prior sleep study.
- BMI is between 28 kg/m2 and 40 kg/m2 at enrollment.
- Negative result for COVID-19 polymerase chain reaction (RT-PCR) test and absence of clinical symptoms for COVID-19.
Key exclusion criteria (21 listed)
- Subjects with a high percentage of central apneas suggesting heart failure.
- Contraindication to general anesthesia or surgery.
- Craniofacial abnormality (e.g. retrognathia, micrognathia, etc.) thought to be the primary cause of OSA.
- Obvious fixed upper airway obstructions (tumors, polyps, nasal obstruction).
- Tonsil size ≥ +3.
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 |
|---|---|---|
| cryotherapyCryotherapy at sites of vibration as origin of snoring and site of collapse for patients with obstructive sleep apnea syndrome | Procedure or surgery | evaluation of cryotherapy as treatment for obstructive sleep apnea patients |
Primary outcome
value, side effect and impact of cryotherapy in treatment of patients with obstructive sleep apnea syndrome
Time frame: polysomnography will done after 2 weeks of intervention
we use drug induced sleep endoscopy during intervention and use polysomnography before the intervention as diagnostic for cases and after intervention for follow up of cases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Individual participant dataSharing planned: No
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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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.
Questions about this trial
What is this clinical trial studying?
A study testing cryotherapy in people with Obstructive Sleep Apnea Syndrome, run by Sohag University.
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 21 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: status not confirmed, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact fatma h mohamed, assistant lecturer (01093199561 ext. mobile, fatma.hassanain@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
value, side effect and impact of cryotherapy in treatment of patients with obstructive sleep apnea syndrome (time frame: polysomnography will done after 2 weeks of intervention). 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 25 Jan 2022.