Obstructive Sleep ApneaNCT05033626
Simultaneous Operations on the Thyroid Gland and Hyoid Suspension in Patients With Combined Thyroid Pathology and OSA
A study testing Simultaneous thyroidectomy and hyoid suspension and Thyroidectomy in people with Obstructive Sleep Apnea and Obstructive Sleep Apnea-hypopnea, run by State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia at 1 site in Russia.
Trial summary
Simultaneous operations on the thyroid gland and hyoid suspension in patients with combined thyroid pathology and moderate to severe OSA. Read more about this study
- Who is it for?
- Ages 30 to 60 years, men only
- Conditions the study is for
- Obstructive Sleep Apnea, Obstructive Sleep Apnea-hypopnea, Obstructive Sleep Apnea-hypopnea Syndrome
- What is being tested?
- Simultaneous thyroidectomy and hyoid suspension and Thyroidectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteRussia
- Study dates
- 15 Oct 2021to 1 May 2024
- 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 30 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- The patient understands the essence of all procedures planned in the framework of an initiative clinical trial and voluntarily confirms his desire to participate by written informed consent;
- Male or female patients with completed skeletal growth at the age of 30 to 60 years, inclusively, with thyroid pathology and moderate to severe OSAS according to cardiorespiratory monitoring with obstruction of the soft tissues of the upper respiratory tract at the levels of the oropharyngeal and laryngopharynx, without radiography of the pathology of the paranasal sinuses;
- Еhe patient is scheduled for thyroid gland surgery (thyroidectomy with / without lymphadenectomy, subtotal resection of the thyroid gland, hemithyroidectomy).
Who cannot join
- Women during pregnancy, childbirth;
- Women during breastfeeding;
- Persons with mental disorders;
- Persons detained, taken into custody, serving a sentence in the form of restriction of freedom, arrest, imprisonment or administrative arrest;
- Chronic somatic diseases in the stage of decompensation. Conditions and concomitant pathology of other organs, which are a contraindication for general anesthesia and intubation;
- Diseases and conditions associated with severe bleeding disorders (hemophilia, von Willebrand disease, deficiency of one or more coagulation factors, etc.);
Show all 12Show fewer
- Infectious diseases in the acute stage.
- Severe brain injuries, which entailed consequences in the form of focal epilepsy, encephalopathy, dementia;
- Pathology of the paranasal sinuses according to X-ray data;
- Pathologies that are relative contraindications for CPAP therapy (bullous lung disease; pulmonary emphysema; a history of pneumothorax, pneumomediastinum, pneumocephalus, respiratory distress syndrome, external liquorrhea; previous surgical interventions on the brain, middle or inner ear, pituitary gland; recurrent sinusitis; recurrent eye infections; severe hypotension; severe dehydration; frequent nosebleeds; fractures of the bones of the face; condition after esophagectomy in history (risk of damage to the anastomosis due to increased pharyngeal / esophageal pressure); hemodynamic instability; a history of severe chronic heart failure; Decompensation of major diseases; cardiomyopathy of any genesis; oncological diseases (except for pathology of the thyroid gland);
- Pathologies that are absolute contraindications for CPAP therapy (unconsciousness of the patient; severe respiratory failure, which may require intubation and subsequent mechanical ventilation; cerebrospinal fluid fistula; collapse of the epiglottis according to sleep endoscopy);
- refusal of the patient to carry out CPAP therapy.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Pirogov National Medical and Surgical Center
Moscow, 105203
Oleg Savchuk, MD, PhD, 89175728719, osavchuk71@mail.ru
Konstantin Apostolidi, Prof, MD
About this study
Official title: Simultaneous Operations on the Thyroid Gland and Hyoid Suspension in Patients With Combined Thyroid Pathology and Obstructive Sleep Apnea (OSA).
Simultaneous operations on the thyroid gland and hyoid suspension in patients with combined thyroid pathology and moderate to severe OSA.
Read the detailed description
The ineffectiveness of conservative treatment of obstructive sleep apnea syndrome (OSAS) (CPAP-therapy) or its rejection leads to a surgical solution of the issue, the purpose of which is to eliminate obvious anatomical obstacles, to increase the lumen of the upper respiratory tract. Modern methods of multilevel surgical treatment of OSAS make it possible to achieve more than 80% success.
Most often, at the first stage of OSAS treatment, otorhinolaryngologists use rhinosurgical techniques such as septoplasty, lower submucosal vasotomy, partial conchotomy, removal of nasal polyps, including using endoscopic techniques. At the subsequent stages of multilevel treatment, depending on the level of obstruction and the severity of OSAS, uvulopalatoplasty or uvulopalatopharyngoplasty, partial resection of the tongue or lingual tonsil, suspension of the tongue root and sublingual system, various types of genioplasty and maxillary reduction are performed.
This approach allows expanding the airways in the oropharyngeal region and laryngopharynx, improving functional outcomes and quality of life in patients with OSAS.
At the same time, first of all, it is necessary to carefully assess the benefits and potential risks of surgical treatment, especially in patients with an unfavorable morbid background and from older age groups.
- The investigators will offer patients with concomitant thyroid pathology and moderate or severe OSAS to perform simultaneous operations from one access, where the hyoid bone to the thyroid cartilage will be sutured in the second stage. The stabilization of the hyoid bone and the muscular frame, as an integral complex of the laryngopharynx, increases the airway space and neutralizes obstruction. (1-3) Under endotracheal anesthesia, a horizontal skin incision up to 5 cm long is made at the level of the upper edge of the thyroid cartilage, the skin and subcutaneous fat are dissected. The sternohyoid and sternothyroid muscles are retracted. An audit of the thyroid gland is performed. Step by step, using the ultrasonic dissector, the sections of the gland necessary for resection are separated, ligated, and transected. The vessels of the upper and lower poles are separated with the preservation of blood supply to the right and left upper and lower parathyroid glands. Using a microsurgical technique, neurolysis of the recurrent laryngeal nerves is performed. The control of the integrity of the recurrent laryngeal nerves was performed using the neuromonitoring apparatus.
The hyoid bone is mobilized in the anterocaudal direction and is fixed to the thyroid cartilage with four permanent non-absorbable sutures. If sufficient mobilization does not occur during the operation, the tendon of the stylohyoid muscle is dissected. Surgical drainage is installed 24 hours after surgery.
Advantages:
- access from one incision with combined pathology of the thyroid gland and OSAS which reduces the need for delayed operations;
- decrease in apnea hypopnea index (AHI) to 50.7% and subjective daytime sleepiness according to foreign literature.
- Conditions
- Obstructive Sleep Apnea, Obstructive Sleep Apnea-hypopnea, Obstructive Sleep Apnea-hypopnea Syndrome
- Being tested
- Simultaneous thyroidectomy and hyoid suspension, Thyroidectomy
- Keywords
- OSA, CPAP, hyoid suspension, hypopharyngeal obstruction
- Medical subject headings
- Sleep Apnea, Obstructive, Microcephaly, Primary Autosomal Recessive, 6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous thyroidectomy and hyoid suspensionProcedure or surgery
Under endotracheal anesthesia, a horizontal skin incision up to 50 mm long is made at the level of the upper thyroid cartilage, the skin and subcutaneous fat are dissected. The sternohyoid and sternothyroid muscles are retracted. An audit of the thyroid gland is performed. Step by step, using the ultrasonic dissector, the sections of the gland necessary for resection are separated, ligated and transected. Using microsurgical techniques, neurolysis of the recurrent laryngeal nerves is performed. The quality control of the return of the laryngeal nerves is ensured to the required extent using the neuromonitoring apparatus.
ThyroidectomyProcedure or surgery
The hyoid bone is mobilized in the anterocaudal direction and is fixed to the thyroid cartilage with four permanent non-absorbable sutures. If sufficient mobilization does not occur during the operation, the tendon of the stylohyoid muscle is dissected. Surgical drainage is installed 24 hours after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Thyroidectomy | Other | Not described Receives: Procedure: Thyroidectomy |
| Simultaneous thyroidectomy and hyoid suspension | Experimental | Not described Receives: Procedure: Simultaneous thyroidectomy and hyoid suspension; Procedure: Thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absence of severe adverse reactions
Shortness of breath, bleeding, suppuration
Measured: Up to 2 months after surgery
Secondary outcomes (10)
The STOP-BANG questionnaire
The STOP-BANG questionnaire provides 8 possible signs of the presence of apnea: loud snoring; stopping breathing during sleep; daytime tiredness; increased blood pressure; BMI> 35; neck circumference ≥ 43 cm (41 cm for women), male and over 50 years of age. If there are 3 or more signs, the risk of sleep apnea is considered to be increased.
Measured: Screening, Day 30 and Day 60
Three-level European quality of life five-dimensional questionnaire
There are five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Patients choice results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describe the health status.
Measured: Screening, Day 30 and Day 60
Apnea-Hypopnea Index (AHI)
Apnea-hypopnea index (AHI) is the total number of episodes of complete or partial cessation of breathing during one hour of sleep (with polysomnography or cardiorespiratory monitoring). AHI is used to assess the severity of OSAS. Calculated using the formula: (number of apnea episodes + number of hypopnea episodes) / sleep or study time.
AHI <5 is considered the norm. Average degree of OSAS 15≤IAG <30. Severe AHI ≥30. A decrease in the indicator shows an improvement in OSAS during treatment.
Measured: Screening, Day 30 and Day 60
The Epworth Sleepiness Scale (ESS)
The Epworth Sleepiness Scale (ESS) is a scale for measuring daytime sleepiness using a questionnaire. Helpful in diagnosing sleep disorders.
Subjects are asked to rate the likelihood of falling asleep on a scale of increasing probability from 0 to 3 for various situations they encounter in everyday life. The scores for the eight questions are added to form a single number. A number in the range of 0-9 is considered normal, while a number in the range of 10-24 indicates that you should seek professional advice.
Measured: Screening, Day 30 and Day 60
Pittsburgh Sleep Quality Index (PSQI) Questionnaire
The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire that assesses sleep quality over a 1 month time frame. It consists of 19 individual elements, making up 7 components that give one overall rating. Each item is weighted on a scale from 0 to 3. The overall PSQI score is then calculated by adding the scores of the seven components to give an overall score of 0 to 21, where lower scores mean healthier sleep quality.
Measured: Screening, Day 30 and Day 60
Cardiorespiratory monitoring
Cardiorespiratory monitoring - is one of the main methods for diagnosing snoring and breathing disorders during sleep. It allows you to identify episodes of snoring and respiratory arrest (apnea) during sleep, to determine the level of oxygen during episodes of disturbed breathing, to reveal the relationship between apnea and disturbances in the rhythm and conduction of the heart, persistent arterial hypertension, and also to establish the degree of OSA
Measured: Screening, Day 60
Native endoscopy of the upper respiratory tract with Müller's test
Upper airway endoscopy with Müller's test is performed with flexible optics in a sitting or supine position of the patient. After a forced exhalation, he inhales with his hand closed to his nose and mouth. Levels, shapes and severity of nasal, pharyngeal and laryngeal obstruction are assessed
Measured: Screening, Day 30 and Day 60
Sleep endoscopy
Sleep endoscopy (drug-induced slip endoscopy (DISE)) is a research method in which the patient is immersed in a drug-induced sleep, at a certain depth of which the sound phenomenon of snoring occurs using a flexible endoscope. All parts of the nose, pharynx and larynx are examined. The degree, shape, and levels of obstruction are determined.
Measured: Screening, Day 60
The intensity of pain assesment
The intensity of pain is quantified using Verbal Rating Scale. The following scale of verbal assessments is applied: 0 - no pain, 1 point - mild, 2 - moderate, 3 - strong, 4 points - very strong and 5 points - unbearable pain.
Measured: On the day of surgery, 2 days after the surgery
Pulse oximetry
Pulse oximetry is an indirect method for assessing ventilation. Estimation of the average values of saturation is important for the detection of chronic nocturnal hypoxemia and respiratory failure during sleep. A decrease in average saturation values below 90% indicates severe respiratory failure during sleep.
Measured: On the day of surgery, 2 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start15 Oct 2021
- Primary completion1 Oct 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oleg Savchuk, State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
- Investigators
- Oleg Savchuk, MD, Principal investigator, Pirogov National Medical Surgical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033626
- Sponsor's protocol ID
- NMSC-02-21
- Status last verified
- Mar 2023
- First submitted
- 27 Aug 2021
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Song SA, Wei JM, Buttram J, Tolisano AM, Chang ET, Liu SY, Certal V, Camacho M. Hyoid surgery alone for obstructive sleep apnea: A systematic review and meta-analysis. Laryngoscope. 2016 Jul;126(7):1702-8. doi: 10.1002/lary.25847. Epub 2016 Jan 23.
PubMed 26801005Canzi P, Berardi A, Tinelli C, Montevecchi F, Pagella F, Vicini C, Benazzo M. Thirteen Years of Hyoid Suspension Experience in Multilevel OSAHS Surgery: The Short-Term Results of a Bicentric Study. Int J Otolaryngol. 2013;2013:263043. doi: 10.1155/2013/263043. Epub 2013 Feb 20.
PubMed 23509464Baisch A, Maurer JT, Hormann K. The effect of hyoid suspension in a multilevel surgery concept for obstructive sleep apnea. Otolaryngol Head Neck Surg. 2006 May;134(5):856-61. doi: 10.1016/j.otohns.2006.01.015.
PubMed 16647548
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Operations on the Thyroid Gland and Hyoid Suspension in Patients With Combined Thyroid Pathology and Obstructive Sleep Apnea (OSA).
- ClinicalTrials.gov ID
- NCT05033626
- Acronym / sponsor ID
- NMSC-02-21
- Conditions
- Obstructive Sleep Apnea, Obstructive Sleep Apnea-hypopnea, Obstructive Sleep Apnea-hypopnea Syndrome
- Keywords
- OSA, CPAP, hyoid suspension, hypopharyngeal obstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of RussiaUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 5 Sep 2021 (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.
Simultaneous operations on the thyroid gland and hyoid suspension in patients with combined thyroid pathology and moderate to severe OSA.
Detailed description
The ineffectiveness of conservative treatment of obstructive sleep apnea syndrome (OSAS) (CPAP-therapy) or its rejection leads to a surgical solution of the issue, the purpose of which is to eliminate obvious anatomical obstacles, to increase the lumen of the upper respiratory tract. Modern methods of multilevel surgical treatment of OSAS make it possible to achieve more than 80% success.
Most often, at the first stage of OSAS treatment, otorhinolaryngologists use rhinosurgical techniques such as septoplasty, lower submucosal vasotomy, partial conchotomy, removal of nasal polyps, including using endoscopic techniques. At the subsequent stages of multilevel treatment, depending on the level of obstruction and the severity of OSAS, uvulopalatoplasty or uvulopalatopharyngoplasty, partial resection of the tongue or lingual tonsil, suspension of the tongue root and sublingual system, various types of genioplasty and maxillary reduction are performed.
This approach allows expanding the airways in the oropharyngeal region and laryngopharynx, improving functional outcomes and quality of life in patients with OSAS.
At the same time, first of all, it is necessary to carefully assess the benefits and potential risks of surgical treatment, especially in patients with an unfavorable morbid background and from older age groups.
- The investigators will offer patients with concomitant thyroid pathology and moderate or severe OSAS to perform simultaneous operations from one access, where the hyoid bone to the thyroid cartilage will be sutured in the second stage. The stabilization of the hyoid bone and the muscular frame, as an integral complex of the laryngopharynx, increases the airway space and neutralizes obstruction. (1-3) Under endotracheal anesthesia, a horizontal skin incision up to 5 cm long is made at the level of the upper edge of the thyroid cartilage, the skin and subcutaneous fat are dissected. The sternohyoid and sternothyroid muscles are retracted. An audit of the thyroid gland is performed. Step by step, using the ultrasonic dissector, the sections of the gland necessary for resection are separated, ligated, and transected. The vessels of the upper and lower poles are separated with the preservation of blood supply to the right and left upper and lower parathyroid glands. Using a microsurgical technique, neurolysis of the recurrent laryngeal nerves is performed. The control of the integrity of the recurrent laryngeal nerves was performed using the neuromonitoring apparatus.
The hyoid bone is mobilized in the anterocaudal direction and is fixed to the thyroid cartilage with four permanent non-absorbable sutures. If sufficient mobilization does not occur during the operation, the tendon of the stylohyoid muscle is dissected. Surgical drainage is installed 24 hours after surgery.
Advantages:
- access from one incision with combined pathology of the thyroid gland and OSAS which reduces the need for delayed operations;
- decrease in apnea hypopnea index (AHI) to 50.7% and subjective daytime sleepiness according to foreign literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thyroidectomy | Other | Procedure: Thyroidectomy |
| Simultaneous thyroidectomy and hyoid suspension | Experimental | Procedure: Simultaneous thyroidectomy and hyoid suspension, Procedure: Thyroidectomy |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The patient understands the essence of all procedures planned in the framework of an initiative clinical trial and voluntarily confirms his desire to participate by written informed consent;
- Male or female patients with completed skeletal growth at the age of 30 to 60 years, inclusively, with thyroid pathology and moderate to severe OSAS according to cardiorespiratory monitoring with obstruction of the soft tissues of the upper respiratory tract at the levels of the oropharyngeal and laryngopharynx, without radiography of the pathology of the paranasal sinuses;
- Еhe patient is scheduled for thyroid gland surgery (thyroidectomy with / without lymphadenectomy, subtotal resection of the thyroid gland, hemithyroidectomy).
Key exclusion criteria (12 listed)
- Women during pregnancy, childbirth;
- Women during breastfeeding;
- Persons with mental disorders;
- Persons detained, taken into custody, serving a sentence in the form of restriction of freedom, arrest, imprisonment or administrative arrest;
- Chronic somatic diseases in the stage of decompensation. Conditions and concomitant pathology of other organs, which are a contraindication for general anesthesia and intubation;
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 |
|---|---|---|
| Simultaneous thyroidectomy and hyoid suspensionUnder endotracheal anesthesia, a horizontal skin incision up to 50 mm long is made at the level of the upper thyroid cartilage, the skin and subcutaneous fat are dissected. The sternohyoid and sternothyroid muscles are retracted. An audit of the thyroid gland is performed. Step by step, using the ultrasonic dissector, the sections of the gland necessary for resection are separated, ligated and transected. Using microsurgical techniques, neurolysis of the recurrent laryngeal nerves is performed. The quality control of the return of the laryngeal nerves is ensured to the required extent using the neuromonitoring apparatus. | Procedure or surgery | Simultaneous thyroidectomy and hyoid suspension |
| ThyroidectomyThe hyoid bone is mobilized in the anterocaudal direction and is fixed to the thyroid cartilage with four permanent non-absorbable sutures. If sufficient mobilization does not occur during the operation, the tendon of the stylohyoid muscle is dissected. Surgical drainage is installed 24 hours after surgery. | Procedure or surgery | Simultaneous thyroidectomy and hyoid suspension, Thyroidectomy |
Primary outcome
The absence of severe adverse reactions
Time frame: Up to 2 months after surgery
Shortness of breath, bleeding, suppuration
10 secondary outcomes
The STOP-BANG questionnaire
Time frame: Screening, Day 30 and Day 60
Three-level European quality of life five-dimensional questionnaire
Time frame: Screening, Day 30 and Day 60
Apnea-Hypopnea Index (AHI)
Time frame: Screening, Day 30 and Day 60
The Epworth Sleepiness Scale (ESS)
Time frame: Screening, Day 30 and Day 60
Pittsburgh Sleep Quality Index (PSQI) Questionnaire
Time frame: Screening, Day 30 and Day 60
Cardiorespiratory monitoring
Time frame: Screening, Day 60
Native endoscopy of the upper respiratory tract with Müller's test
Time frame: Screening, Day 30 and Day 60
Sleep endoscopy
Time frame: Screening, Day 60
The intensity of pain assesment
Time frame: On the day of surgery, 2 days after the surgery
Pulse oximetry
Time frame: On the day of surgery, 2 days after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Results publication: PubMed 26801005Song SA, Wei JM, Buttram J, Tolisano AM, Chang ET, Liu SY, Certal V, Camacho M. Hyoid surgery alone for obstructive sleep apnea: A systematic review and meta-analysis. Laryngoscope. 2016 Jul;126(7):1702-8. doi: 10.1002/lary.25847. Epub 2016 Jan 23.
- Results publication: PubMed 23509464Canzi P, Berardi A, Tinelli C, Montevecchi F, Pagella F, Vicini C, Benazzo M. Thirteen Years of Hyoid Suspension Experience in Multilevel OSAHS Surgery: The Short-Term Results of a Bicentric Study. Int J Otolaryngol. 2013;2013:263043. doi: 10.1155/2013/263043. Epub 2013 Feb 20.
- Results publication: PubMed 16647548Baisch A, Maurer JT, Hormann K. The effect of hyoid suspension in a multilevel surgery concept for obstructive sleep apnea. Otolaryngol Head Neck Surg. 2006 May;134(5):856-61. doi: 10.1016/j.otohns.2006.01.015.
- Individual participant dataSharing planned: Yes
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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.
Oleg Savchuk, MD principal investigator
Pirogov National Medical Surgical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simultaneous thyroidectomy and hyoid suspension and Thyroidectomy in people with Obstructive Sleep Apnea and Obstructive Sleep Apnea-hypopnea, run by State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia at 1 site in Russia.
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 12 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 28 Mar 2023. 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 Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oleg Savchuk, MD, PhD (+79175728719, osavchuk71@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The absence of severe adverse reactions (time frame: Up to 2 months after surgery). 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 NCT05033626, which also lists 3 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 28 Mar 2023.