Moderate Obstructive Sleep Apnea SyndromePhase 3SAOSGENIONCT05911971
Upper Airway Reeducation in Moderate Obstructive Sleep Apnea Syndrome
A Phase 3 study testing Experimental in people with Moderate Obstructive Sleep Apnea Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of this study is to evaluate the effectiveness of a specific reeducation performed by speech therapists in moderate obstructive sleep apnea syndrome, as an alternative to the continuous Positive Anyway Pressure (CPAP) and the mandibular advancement device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate Obstructive Sleep Apnea Syndrome
- What is being tested?
- Experimental
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2023to Oct 2026
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 years old minimum
- Diagnosis of moderate OSAS: AHI ≥ 15 events/h and < 30 events/h at PSG M0
- BMI < 35 kg/m2
Who cannot join
- MoCA < 26 (Montreal Cognitive Assessment)
- Craniofacial malformations
- Regular use of hypnotic medications
- Untreated hypothyroidism
- Stroke history
- Cardiac insufficiency
Show all 15Show fewer
- Severe uncontrolled coronary heart disease
- Severe obstructive nasal disease
- Patients with indication for CPAP in first intention
- Pregnant or breastfeeding woman
- Current participation in another interventional research in OSA
- No affiliation to a social security system or legal beneficiary (except AME,Aide médicale d'état)
- Absence of free, informed, written consent
- Contraindications for TMS: intracranial metallic implant, pacemaker and/or recent or severe cardiac disease, epilepsy, vascular, traumatic, tumor, infectious or metabolic brain lesions, severe alcoholism
- Protected adult under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
France1 site
Service des pathologies du sommeil, Pitié-Salpêtrière hospital
Paris, 75013
Diane PICARD-DUBOIS, 0142163157, diane.picard@aphp.fr
Diane PICARD-DUBOIS
About this study
Official title: Specific Upper Airway Reeducation in Moderate Obstructive Sleep Apnea Syndrome: a Randomized Controlled Trial
The aim of this study is to evaluate the effectiveness of a specific reeducation performed by speech therapists in moderate obstructive sleep apnea syndrome, as an alternative to the continuous Positive Anyway Pressure (CPAP) and the mandibular advancement device.
Read the detailed description
Patients will be recruited in the sleep pathology department, following a sleep consultation and/or a polysomnography. They will be randomized between 2 reeducation groups (specific reeducation or sham reeducation) and will have to perform their respective exercises during 3 months. Only one of the 2 reeducations is expected to be effective. To limit performance and measure bias, patients will not be aware of the content of the reeducation in the other group (participants partially blinded of study hypothesis) and therefore these are not described in detail here. The initial clinical assessment will be repeated at 3 and 6 months, by assessors blinded to the reeducation arm, in order to evaluate the short and medium term effectiveness on the the Apnea-Hypopnea Index (AHI) and other outcomes.
- Being tested
- Experimental, Sham comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
specific reeducation (not detailed to maintain blinding of participants)
Sham comparatorOther
sham reeducation (not detailed to maintain blinding of participants)
| Study group | Role | What they receive |
|---|---|---|
| Specific reeducation | Experimental | Specific reeducation Receives: Other: Experimental |
| Sham comparator | Sham comparator | Sham reeducation Receives: Other: Sham comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in apnea-hypopnea index (AHI)
Apnea-hypopnea index (AHI) is the number of apnoeas or hypopnoeas per hour of sleep, measured by polysomnography during a minimum 6-hour night of inpatient sleep. Polysomnograms will be interpreted by a blinded somnologist.
Measured: between 0 and 3 months after randomization
Secondary outcomes (32)
Change of the Apnea-Hypopnea Index (AHI)
Apnea-hypopnea index (AHI) is the number of apnoeas or hypopnoeas per hour of sleep, measured by polysomnography during a minimum 6-hour night of inpatient sleep. Polysomnograms will be interpreted by a blinded somnologist.
Measured: between 0 and 6 months after randomization
Change of the MBLF(Bucco-Linguo-Facial Motor Function) score
Quantitative evaluation of the patient's lingual mobility by the speech therapist. The test consists of the execution of 13 lingual praxias rated from 0 (no contraction) to 3 (normal contraction), with a total score from 0 to 39
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Change of the lingual strength
measured by collecting the maximum pressure in kPa with an tongueometer.
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Change of lingual endurance
Following the same principle as lingual strength, lingual endurance (inversely proportional to fatigability) is measured with a tongueometer by quantifying the duration during which the patient can maintain 50% of his maximum pressure. The target value is then set to 50% of the patient's maximum pressure and the duration (in seconds)
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Change of the size of the genioglossus representation in cm² within the motor cortex
by collecting motor evoked potentials of the genioglossus in response to transcranial magnetic stimulation (TMS) applied to the anterolateral region of the right vertex between 0 and 3 months.
Measured: between 0 and 3 months after randomization
Change of quality of life on the SF-36
Quality of life will be studied by the SF-36 generalist questionnaire completed by the patient. 36 items divided into 9 dimensions: physical activity, limitations due to physical condition, physical pain, perceived health, vitality, life and relationships with others, psychological health, limitations due to psychological condition, evolution of perceived health. Score from 0 (minimum subjective health) to 100 (maximum subjective health).
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Change of sleep quality on the Pittsburgh Sleep Quality Index
Sleep quality will be studied by the Pittsburgh Sleep Quality Index completed by the patient.19 questions are divided into 7 composite scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, medication use, daytime dysfunctions) ranging from 0 (no difficulty) to 3 (severe difficulty). The global score is calculated by adding the 7 composite scores, the score obtained ranging from 0 to 21. The quality of sleep is investigated over the previous month.
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Change of daytime drowsiness on the Epworth Drowsiness Scale
Daytime drowsiness will be studied by the Epworth Drowsiness Scale completed by the patient. 8 items rated from 0 (no chance of drowsiness) to 3 (systematic drowsiness), total score from 0 to 24. A score greater than or equal to 11 corresponds to daytime sleepiness.
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Presence of subjective symptoms , each taken independently
subjective evaluation by the patient following questions:snoring every night or so (yes/no), high intensity of snoring (heard through a door or complaint from the entourage (yes/no),nocturia (yes/no) if yes frequency of episodes, morning headaches (yes/no),dry mouth at night or upon waking (yes/no),impression of non-restorative sleep (yes/no),bad sleep (yes/no), if yes, number of awakenings per nigh, fatigue (yes/no), daytime sleepiness (yes/no),impatience in the legs (yes/no),nightmares (yes/no), other symptoms (yes/no)
Measured: At 3 months and 6 months after randomization
Change of the cervical circumference measurement (at the level of the cricoid)
in cm, using a tape measure
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Change of the respiratory sensation sitting at rest
Using a visual analogue scale, consisting of a 10 cm plastic ruler graduated in mm presented horizontally. The side presented to the patient has a straight non graduated line, the left end of which corresponds to "no respiratory discomfort" and the right end to "intolerable respiratory discomfort".On the other side, there are millimetre graduations only visible to speech therapist. The position of the cursor chosen by the patient allows to read the intensity of the respiratory discomfort, which is measured in mm
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Change of change in respiratory sensation between sitting and full decubitus
after the measurement of the respiratory sensation while sitting at rest, the patient is put in complete decubitus and the change of his respiratory discomfort between these 2 positions is measured. This change is collected using a visual analog scale, consisting of a 10 cm plastic ruler graduated in mm presented horizontally. The side presented to the patient has a straight, non-scaled line with "maximum aggravation" at the left end to "maximum improvement" at the right end, with a central marker to indicate "no change". On the other side, there are millimeter graduations only visible to speech therapist. The position of the cursor chosen by the patient allows to read the intensity of the respiratory discomfort, the results are expressed as a percentage of the full scale, the latter being defined as the distance between the central marker and one of the extremities, with a "+" sign for improvement and a "-" sign for worsening which is measured in mm.
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Change of sleep latency
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Change of N3 latency
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Change of the paradoxical sleep latency
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
Measured: between 0 and 3 months and between 0 and 6 months after randomization
change of sleep efficiency
calculated as total sleep time (TST) versus time from sleep to wakefulness (TWA), during polysomnography in a minimum 6-hour night of inpatient sleep
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Change of the total sleep time (TST)
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Change of the length of the N1
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Change of the percentage (related to the TST) of the N1
measured in percentage of TST, during polysomnography in a minimum 6-hour night of inpatient sleep
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Change of the length of the N2
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Change of the percentage (related to the TST) of the N2
measured in percentage of TST, during polysomnography in a minimum 6-hour night of inpatient sleep
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Change of the length of the N3
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Change of the percentage (related to the TST) of the N3
measured in percentage of TST, during polysomnography in a minimum 6-hour night of inpatient sleep
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Change of the length of paradoxical sleep
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Change of the percentage (related to the TST) of paradoxical sleep
measured in percentage of TST, during polysomnography in a minimum 6-hour night of inpatient sleep
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Change of the length of intrasleep vigil
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Change of the percentage (related to the TST) of intrasleep vigil
measured in percentage of TST, during polysomnography in a minimum 6-hour night of inpatient sleep
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Change of the index of micro-awakenings
Is the number of micro-awakenings per hour of sleep, measured by polysomnography during a minimum 6-hour night of inpatient sleep.
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Change of the index of micro-awakenings of respiratory origin
Is the number of micro-awakenings of respiratory origin per hour of sleep, measured by polysomnography during a minimum 6-hour night of inpatient sleep.
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Change of the number of periodic leg movements
Is the number of periodic leg movements per hour of sleep, measured by polysomnography during a minimum 6-hour night of inpatient sleep.
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Change of number of sleep cycles
Is the number of sleep cycle, measured by polysomnography during a minimum 6-hour night of inpatient sleep.
Measured: between 0 and 3 months and between 0 and 6 months after randomization
Compliance with treatment
declared by the patient via the logbook given to the patient at the initial assessment. After each exercises session, the patient will have to complete the day, indicate the time spent and any difficulties encountered. Telephone follow-up of compliance will be carried out by the speech therapist or the clinical study technician every month. Compliance will be evaluated by the percentage of days when the patient will have declared to have carried out exercises for a duration higher than 50% of the theoretical duration of the exercises session
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study startJul 2023 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diane PICARD-DUBOIS, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911971
- Sponsor's protocol ID
- APHP210997
- Other IDs
- 2021-A02688-33
- Acronym
- SAOSGENIO
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Upper Airway Reeducation in Moderate Obstructive Sleep Apnea Syndrome: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05911971
- Acronym / sponsor ID
- SAOSGENIO / APHP210997
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 22 Jun 2023 (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.
The aim of this study is to evaluate the effectiveness of a specific reeducation performed by speech therapists in moderate obstructive sleep apnea syndrome, as an alternative to the continuous Positive Anyway Pressure (CPAP) and the mandibular advancement device.
Detailed description
Patients will be recruited in the sleep pathology department, following a sleep consultation and/or a polysomnography. They will be randomized between 2 reeducation groups (specific reeducation or sham reeducation) and will have to perform their respective exercises during 3 months. Only one of the 2 reeducations is expected to be effective. To limit performance and measure bias, patients will not be aware of the content of the reeducation in the other group (participants partially blinded of study hypothesis) and therefore these are not described in detail here. The initial clinical assessment will be repeated at 3 and 6 months, by assessors blinded to the reeducation arm, in order to evaluate the short and medium term effectiveness on the the Apnea-Hypopnea Index (AHI) and other outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specific reeducation | Experimental | Other: ExperimentalSpecific reeducation |
| Sham comparator | Sham comparator | Other: Sham comparatorSham reeducation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, 18 years old minimum
- Diagnosis of moderate OSAS: AHI ≥ 15 events/h and < 30 events/h at PSG M0
- BMI < 35 kg/m2
Key exclusion criteria (15 listed)
- MoCA < 26 (Montreal Cognitive Assessment)
- Craniofacial malformations
- Regular use of hypnotic medications
- Untreated hypothyroidism
- Stroke history
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 |
|---|---|---|
| Experimentalspecific reeducation (not detailed to maintain blinding of participants) | Other | Specific reeducation |
| Sham comparatorsham reeducation (not detailed to maintain blinding of participants) | Other | Sham comparator |
Primary outcome
Change in apnea-hypopnea index (AHI)
Time frame: between 0 and 3 months after randomization
Apnea-hypopnea index (AHI) is the number of apnoeas or hypopnoeas per hour of sleep, measured by polysomnography during a minimum 6-hour night of inpatient sleep. Polysomnograms will be interpreted by a blinded somnologist.
32 secondary outcomes
Change of the Apnea-Hypopnea Index (AHI)
Time frame: between 0 and 6 months after randomization
Change of the MBLF(Bucco-Linguo-Facial Motor Function) score
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Change of the lingual strength
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Change of lingual endurance
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Change of the size of the genioglossus representation in cm² within the motor cortex
Time frame: between 0 and 3 months after randomization
Change of quality of life on the SF-36
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Change of sleep quality on the Pittsburgh Sleep Quality Index
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Change of daytime drowsiness on the Epworth Drowsiness Scale
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Presence of subjective symptoms , each taken independently
Time frame: At 3 months and 6 months after randomization
Change of the cervical circumference measurement (at the level of the cricoid)
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Change of the respiratory sensation sitting at rest
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Change of change in respiratory sensation between sitting and full decubitus
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Change of sleep latency
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Change of N3 latency
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Change of the paradoxical sleep latency
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
change of sleep efficiency
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Change of the total sleep time (TST)
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Change of the length of the N1
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Change of the percentage (related to the TST) of the N1
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Change of the length of the N2
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Change of the percentage (related to the TST) of the N2
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Change of the length of the N3
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Change of the percentage (related to the TST) of the N3
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Change of the length of paradoxical sleep
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Change of the percentage (related to the TST) of paradoxical sleep
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Change of the length of intrasleep vigil
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Change of the percentage (related to the TST) of intrasleep vigil
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Change of the index of micro-awakenings
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Change of the index of micro-awakenings of respiratory origin
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Change of the number of periodic leg movements
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Change of number of sleep cycles
Time frame: between 0 and 3 months and between 0 and 6 months after randomization
Compliance with treatment
Time frame: at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations
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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.
Diane PICARD-DUBOIS principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental in people with Moderate Obstructive Sleep Apnea Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 15 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 22 Jun 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 France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Diane PICARD-DUBOIS (0142163157, diane.picard@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in apnea-hypopnea index (AHI) (time frame: between 0 and 3 months after randomization). 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 22 Jun 2023.