Sleep Disorders Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People between 22 and 70 years of age
• People who are unable to use, refuse to use, or cannot tolerate CPAP or a mouth device (mandibular advancement device) for sleep apnea — or, if using one, are doing so for less than 4 hours a night on fewer than 5 days a week
• People for whom other treatments have not worked, who were not considered suitable candidates, or who have declined other options such as nerve stimulation surgery or certain medications for sleep apnea
• People with a BMI (body mass index) between 30 and 40 at the time of enrolment
• People whose sleep study results show an AHI (a measure of sleep apnea severity) of 30 or higher, OR an AHI of 15 or higher combined with a BMI of 30 or higher, based on an in-lab sleep study
• People who live close enough to the trial site to attend regularly
• People who are willing and able to sign a written consent form to take part

Who may not be able to join:

• People for whom general anaesthesia would not be safe, or who the investigator does not believe could safely tolerate the procedure
• People currently taking ACE inhibitors or ARBs (a type of blood pressure medication)
• People currently receiving allergy immunotherapy (allergy shots) who are unwilling to stop at least 2 weeks before the procedure — note: a 2-week pause may make someone eligible (confirm with trial site)
• People with severe uncontrolled asthma
• People with a severe jaw or facial structure problem that the investigator believes is the main cause of their sleep apnea
• People with a clear, severe blockage in the upper airway, such as tumours, polyps, or significant nasal obstruction
• People who have had surgery on the soft tissue of the upper airway (such as the uvula, soft palate, or tonsils) within the 12 weeks before the scheduled procedure
• People with oral (mouth) cancer or wounds in the mouth that are not healing
• People who have previously had sleep-related surgery, including tongue base reduction, UPPP, or hypoglossal nerve stimulation
• People who have previously received radiation therapy to the neck or upper airway
• People who have had surgical removal of cancer or correction of a birth-related condition in the voice box, tongue, or throat (tonsil or adenoid removal is an exception)
• People with a history of cold urticaria (a skin reaction triggered by cold) or a condition called cryoglobulinemia
• People with a known allergy to glycerin
• People who were hospitalised and placed on a mechanical ventilator due to COVID-19 (at the investigator's discretion)
• People with high blood pressure that remains uncontrolled despite taking three different blood pressure medications at the highest tolerated doses
• People with a diagnosed autoimmune condition, including thyroid disease, lupus, multiple myeloma, or chronic lymphocytic leukaemia
• People with a neuromuscular or neurological condition, such as multiple sclerosis, muscular dystrophy, Parkinson's disease, epilepsy, or a history of stroke or mini-stroke (TIA)
• People with a moderate to severe chronic lung condition (COPD)
• People with active, severe lung vascular disease, such as pulmonary arterial hypertension or pulmonary embolism, or a history of airway-related angioedema (sudden swelling)
• People with hereditary angioedema or other autoimmune conditions that could cause swelling, confirmed by a specific blood test result below a set level
• People with uncontrolled diabetes with a blood sugar control measure (HbA1c) above 9
• People currently being treated for severe heart valve problems, advanced heart failure (NYHA Class III or IV), unstable chest pain, a heart attack within the last 12 months, or severe irregular heart rhythms
• People with a history of a bleeding disorder, impaired immune system, or a heart attack or stroke within the last 12 months
• People with severe kidney failure (Stage 4 or 5) who are on dialysis or expected to need it within 6 months
• People with a history or current signs of TIA, stroke, or muscle dysfunction
• People who currently smoke one pack or more of cigarettes per day
• People who work rotating or night shifts, or expect to do so in the next 2 years
• People whose sleep habits are likely to interfere with the accuracy of sleep study measurements
• People with a known active substance use disorder
• People with other significant sleep disorders that could affect how sleepiness is measured, such as narcolepsy with cataplexy, severe insomnia, or insomnia related to chronic pain or PTSD
• People taking certain medications that could affect the study results, including benzodiazepines, sleeping tablets such as zolpidem or eszopiclone, opioids, antipsychotics, phenothiazines, or prescription stimulants
• People with an active psychiatric condition — such as psychosis, major depression, or severe anxiety — that would prevent them from meeting study requirements or giving informed consent
• People who are pregnant, or people of childbearing age who plan to become pregnant within 3 months of the treatment date
• People who are currently taking part in another investigational (pre-market) study, unless the trial sponsor has given written approval
• People the investigator considers unsuitable for any other reason

Important: Always verify eligibility with the trial site directly before applying.