Obstructive Sleep Apnea of AdultNCT06277115
Acute and Long-term Effects of CPAP in OSA
A study testing Continuous positive airway pressure (CPAP) in people with Obstructive Sleep Apnea of Adult, run by University of Zurich at 1 site in Switzerland.
Trial summary
Two-phase interventional non-inferiority trial (phase 1: at least 8 weeks of CPAP; phase 2: 2 weeks of CPAP withdrawal) including 32 patients with moderate to severe OSA to compare the physiological consequences of a short-term CPAP withdrawal to the changes in previously untreated OSA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea of Adult
- What is being tested?
- Continuous positive airway pressure (CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2021to 1 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Untreated moderate or severe OSA with an apnoea-hypopnoea-index (AHI) of ≥ 20/h and an oxygen desaturation index (>3%-dips) of ≥ 20/h in an in-laboratory sleep study
- Epworth Sleepiness Scale Score ≥7/24 points
- Indication for CPAP therapy
- Written informed consent
Who cannot join
- Moderate or more severe obstructive or restrictive ventilatory disorder (FEV1 or FVC < 70%)
- Heart failure
- Other types of sleep-related breathing disorders, e.g. sleep-associated hypoventilation, central sleep apnoea, Cheyne Stoke's Breathing
- Hypoxic or hypercapnic respiratory failure (awake paO2 < 9 kPa or paCO2 > 6 kPa)
- Active treatment for OSA (CPAP, mandibular advancement device, hypoglossal nerve stimulation)
- Current professional driver or previous sleepiness-related accidents
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute, Intermediate and Long-term Effects of CPAP Therapy in Obstructive Sleep Apnoea: a Two-phase Interventional Trial.
Two-phase interventional non-inferiority trial (phase 1: at least 8 weeks of CPAP; phase 2: 2 weeks of CPAP withdrawal) including 32 patients with moderate to severe OSA to compare the physiological consequences of a short-term CPAP withdrawal to the changes in previously untreated OSA. The trial has been designed as a validation of the CPAP-withdrawal model. Baseline in-laboratory sleep studies will be performed prior to CPAP initiation, after 6-8 weeks on CPAP (treatment effect) and following 2 weeks of CPAP therapy withdrawal (withdrawal effect, effect of OSA recurrence).
Read the detailed description
Background and Aim: Obstructive sleep apnoea (OSA) is a prevalent sleep-related breathing disorder. OSA is associated with daytime sleepiness, impaired quality of life, and adverse cardiovascular outcome. OSA can be effectively treated with nocturnal continuous positive airway pressure (CPAP) that restores normal breathing during sleep by preventing upper airway collapse. However, many patients in whom treatment of OSA is indicated are not able to adhere to CPAP, and the consequences of untreated OSA seem to differ between OSA phenotypes. Therefore, treatment alternatives to CPAP and a better understanding of treatment implications in different phenotypes of OSA are important targets in this research field. Thus, effective and controlled study designs are needed to address these research questions. Conventional randomised controlled CPAP trials are limited by low CPAP adherence resulting in an underestimation of the treatment effect. In addition, the impracticability of withholding an effective treatment from symptomatic patients resulting in inclusion of less symptomatic and patients with less severe OSA has limited the conclusions from previous trials. The CPAP therapy withdrawal model was introduced to allow studying the pathophysiological consequences of OSA and treatment effects of CPAP in an effective and controlled way. Optimally treated patients previously diagnosed with OSA established on CPAP therapy are included and undergo a short-term therapy interruption. A therapy withdrawal results in recurrence of OSA and pathophysiological changes can be attributed to OSA in this controlled model. However, it is uncertain whether the consequences of OSA during a short-term CPAP therapy withdrawal are comparable to long-term consequences of untreated OSA.
The aim of this two-phase interventional trial is to assess the effects of intermediate and long-term CPAP therapy as well as acute CPAP therapy withdrawal resulting in OSA recurrence compared to longstanding untreated OSA on cardiovascular and symptom outcomes in moderate and severe OSA. The objective is to study the comparability of conventional CPAP therapy trials with the CPAP withdrawal model in terms of evaluating relevant cardiovascular and patient-centred outcomes in OSA.
The investigators hypothesise that the treatment effect of CPAP in previously treatment-naïve patients with OSA - if adherent to CPAP - will support the same conclusions on OSA pathophysiology and therapy effects as a short-term CPAP withdrawal in treatment-adherent patients having a recurrence of OSA in response to CPAP withdrawal and thus support the use of this effective CPAP withdrawal model to use as future study design in interventional trials in OSA. It is hypothesised that the CPAP withdrawal is non-inferior to conventional CPAP trials in studying the effect on blood pressure and OSA-symptoms.
- Conditions
- Obstructive Sleep Apnea of Adult
- Being tested
- Continuous positive airway pressure (CPAP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressure (CPAP)Device
Nocturnal continuous positive airway pressure therapy is the gold standard treatment for symptomatic OSA. It provides positive pressure via a nasal or oronasal mask to prevent upper airway collapse during sleep.
| Study group | Role | What they receive |
|---|---|---|
| Single arm (therapy initiation followed by therapy withdrawal) | Other | Continuous positive airway pressure (CPAP) Receives: Device: Continuous positive airway pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nocturnal systolic blood pressure
Ambulatory blood pressure monitoring (ABPM)
Measured: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Epworth Sleepines Scale Score (ESS)
Subjective sleepiness, ESS min-max 0-24 points and ESS >10 indicating pathological daytime sleepiness
Measured: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Secondary outcomes (20)
48h, 24h, diurnal and nocturnal systolic and diastolic blood pressure
ABPM
Measured: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Office systolic and diastolic blood pressure
Morning office blood pressure
Measured: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
48h, 24h, diurnal, nocturnal and office heart rate
Heart rate from ABPM, office measurement and from sleep studies
Measured: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Heart rate variability in the time and frequency domain (CV, RMSSD, pRR50, LF, HF, LF/HF)
Measures of heart rate variability (daytime and nighttime)
Measured: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Blood pressure variability (BPV, systolic and diastolic)
BPV from ABPM and beat-to-beat blood pressure measurement
Measured: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Baroreflex sensitivity (BRS)
Finometer
Measured: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Arterial stiffness
ABPM
Measured: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Measures of nocturnal hypoventilation (median and maximal transcutaneous partial pressure of CO2 = tcpCO2)
Sleep study parameters
Measured: at baseline and at least 8 weeks of CPAP as well as after 2 weeks of CPAP withdrawal
Measures of nocturnal hypoxaemia (mean nocturnal oxygen saturation = ¢SpO2)
Sleep study parameters
Measured: at baseline and at least 8 weeks of CPAP as well as after 2 weeks of CPAP withdrawal
Measures of nocturnal hypoxaemia (time spent with SpO2 below 90% = t<90)
Sleep study parameters
Measured: at baseline and at least 8 weeks of CPAP as well as after 2 weeks of CPAP withdrawal
Measures of nocturnal hypoxaemia (hypoxic burden)
Sleep study parameters
Measured: at baseline and at least 8 weeks of CPAP as well as after 2 weeks of CPAP withdrawal
Measures of OSA severity (apnoea-hypopnoea-index)
Sleep study parameters
Measured: at baseline and at least 8 weeks of CPAP as well as after 2 weeks of CPAP withdrawal
Measures of OSA severity (oxygen-desaturation index)
Sleep study parameters
Measured: at baseline and at least 8 weeks of CPAP as well as after 2 weeks of CPAP withdrawal
Sleepiness (Stanford Sleepiness Scale (SSS))
Questionnaire; 7-point Likert scale to quantify a patient's sleepiness at the time the questionnaire is completed; highr scores indicate more sleepiness
Measured: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Fatigue (fatigue severity scale (FSS))
Questionnaire; 9 items, higher score indicates more fatigue
Measured: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Disease-specific quality of life (Functional Outcomes of Sleep Questionnaire (FOSQ))
Questionnaires, Disease-specific quality of life questionnaire to determine functional status in adults; measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living and the extent to which these abilities are improved by effective treatment; 30 items; higher scores are better
Measured: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Superoxide dismutase
Marker of oxidative stress (U/ml)
Measured: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Urinary catecholamines
Epinephrine and norepinephrine in morning urine (nnmol/mmol)
Measured: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Pulse rise index (>6 beats per minute)
from nocturnal oximetry
Measured: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Nocturnal oxymetry measures (¢SpO2, t<90, ODI-3%, ODI-4%)
nocturnal pulse oximetry
Measured: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Feb 2021
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Model description
- Two-phase intervention: several weeks of CPAP therapy followed by two weeks CPAP therapy withdrawal
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esther Irene Schwarz, University of Zurich
- Investigators
- Esther I Schwarz, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277115
- Sponsor's protocol ID
- BASEC Nr. 2020-02002
- Status last verified
- Dec 2024
- First submitted
- 10 Feb 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute, Intermediate and Long-term Effects of CPAP Therapy in Obstructive Sleep Apnoea: a Two-phase Interventional Trial.
- ClinicalTrials.gov ID
- NCT06277115
- Acronym / sponsor ID
- BASEC Nr. 2020-02002
- Conditions
- Obstructive Sleep Apnea of Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 26 Feb 2024 (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.
Two-phase interventional non-inferiority trial (phase 1: at least 8 weeks of CPAP; phase 2: 2 weeks of CPAP withdrawal) including 32 patients with moderate to severe OSA to compare the physiological consequences of a short-term CPAP withdrawal to the changes in previously untreated OSA. The trial has been designed as a validation of the CPAP-withdrawal model. Baseline in-laboratory sleep studies will be performed prior to CPAP initiation, after 6-8 weeks on CPAP (treatment effect) and following 2 weeks of CPAP therapy withdrawal (withdrawal effect, effect of OSA recurrence).
Detailed description
Background and Aim: Obstructive sleep apnoea (OSA) is a prevalent sleep-related breathing disorder. OSA is associated with daytime sleepiness, impaired quality of life, and adverse cardiovascular outcome. OSA can be effectively treated with nocturnal continuous positive airway pressure (CPAP) that restores normal breathing during sleep by preventing upper airway collapse. However, many patients in whom treatment of OSA is indicated are not able to adhere to CPAP, and the consequences of untreated OSA seem to differ between OSA phenotypes. Therefore, treatment alternatives to CPAP and a better understanding of treatment implications in different phenotypes of OSA are important targets in this research field. Thus, effective and controlled study designs are needed to address these research questions. Conventional randomised controlled CPAP trials are limited by low CPAP adherence resulting in an underestimation of the treatment effect. In addition, the impracticability of withholding an effective treatment from symptomatic patients resulting in inclusion of less symptomatic and patients with less severe OSA has limited the conclusions from previous trials. The CPAP therapy withdrawal model was introduced to allow studying the pathophysiological consequences of OSA and treatment effects of CPAP in an effective and controlled way. Optimally treated patients previously diagnosed with OSA established on CPAP therapy are included and undergo a short-term therapy interruption. A therapy withdrawal results in recurrence of OSA and pathophysiological changes can be attributed to OSA in this controlled model. However, it is uncertain whether the consequences of OSA during a short-term CPAP therapy withdrawal are comparable to long-term consequences of untreated OSA.
The aim of this two-phase interventional trial is to assess the effects of intermediate and long-term CPAP therapy as well as acute CPAP therapy withdrawal resulting in OSA recurrence compared to longstanding untreated OSA on cardiovascular and symptom outcomes in moderate and severe OSA. The objective is to study the comparability of conventional CPAP therapy trials with the CPAP withdrawal model in terms of evaluating relevant cardiovascular and patient-centred outcomes in OSA.
The investigators hypothesise that the treatment effect of CPAP in previously treatment-naïve patients with OSA - if adherent to CPAP - will support the same conclusions on OSA pathophysiology and therapy effects as a short-term CPAP withdrawal in treatment-adherent patients having a recurrence of OSA in response to CPAP withdrawal and thus support the use of this effective CPAP withdrawal model to use as future study design in interventional trials in OSA. It is hypothesised that the CPAP withdrawal is non-inferior to conventional CPAP trials in studying the effect on blood pressure and OSA-symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Two-phase intervention: several weeks of CPAP therapy followed by two weeks CPAP therapy withdrawal
| Arm | Type | Receives |
|---|---|---|
| Single arm (therapy initiation followed by therapy withdrawal) | Other | Device: Continuous positive airway pressure (CPAP)Continuous positive airway pressure (CPAP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Untreated moderate or severe OSA with an apnoea-hypopnoea-index (AHI) of ≥ 20/h and an oxygen desaturation index (>3%-dips) of ≥ 20/h in an in-laboratory sleep study
- Epworth Sleepiness Scale Score ≥7/24 points
- Indication for CPAP therapy
- Written informed consent
Key exclusion criteria (7 listed)
- Moderate or more severe obstructive or restrictive ventilatory disorder (FEV1 or FVC < 70%)
- Heart failure
- Other types of sleep-related breathing disorders, e.g. sleep-associated hypoventilation, central sleep apnoea, Cheyne Stoke's Breathing
- Hypoxic or hypercapnic respiratory failure (awake paO2 < 9 kPa or paCO2 > 6 kPa)
- Active treatment for OSA (CPAP, mandibular advancement device, hypoglossal nerve stimulation)
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 |
|---|---|---|
| Continuous positive airway pressure (CPAP)Nocturnal continuous positive airway pressure therapy is the gold standard treatment for symptomatic OSA. It provides positive pressure via a nasal or oronasal mask to prevent upper airway collapse during sleep. | Device | Single arm (therapy initiation followed by therapy withdrawal) |
Primary outcome
Nocturnal systolic blood pressure
Time frame: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Ambulatory blood pressure monitoring (ABPM)
Epworth Sleepines Scale Score (ESS)
Time frame: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Subjective sleepiness, ESS min-max 0-24 points and ESS >10 indicating pathological daytime sleepiness
20 secondary outcomes
48h, 24h, diurnal and nocturnal systolic and diastolic blood pressure
Time frame: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Office systolic and diastolic blood pressure
Time frame: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
48h, 24h, diurnal, nocturnal and office heart rate
Time frame: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Heart rate variability in the time and frequency domain (CV, RMSSD, pRR50, LF, HF, LF/HF)
Time frame: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Blood pressure variability (BPV, systolic and diastolic)
Time frame: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Baroreflex sensitivity (BRS)
Time frame: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Arterial stiffness
Time frame: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Measures of nocturnal hypoventilation (median and maximal transcutaneous partial pressure of CO2 = tcpCO2)
Time frame: at baseline and at least 8 weeks of CPAP as well as after 2 weeks of CPAP withdrawal
Measures of nocturnal hypoxaemia (mean nocturnal oxygen saturation = ¢SpO2)
Time frame: at baseline and at least 8 weeks of CPAP as well as after 2 weeks of CPAP withdrawal
Measures of nocturnal hypoxaemia (time spent with SpO2 below 90% = t<90)
Time frame: at baseline and at least 8 weeks of CPAP as well as after 2 weeks of CPAP withdrawal
Measures of nocturnal hypoxaemia (hypoxic burden)
Time frame: at baseline and at least 8 weeks of CPAP as well as after 2 weeks of CPAP withdrawal
Measures of OSA severity (apnoea-hypopnoea-index)
Time frame: at baseline and at least 8 weeks of CPAP as well as after 2 weeks of CPAP withdrawal
Measures of OSA severity (oxygen-desaturation index)
Time frame: at baseline and at least 8 weeks of CPAP as well as after 2 weeks of CPAP withdrawal
Sleepiness (Stanford Sleepiness Scale (SSS))
Time frame: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Fatigue (fatigue severity scale (FSS))
Time frame: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Disease-specific quality of life (Functional Outcomes of Sleep Questionnaire (FOSQ))
Time frame: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Superoxide dismutase
Time frame: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Urinary catecholamines
Time frame: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Pulse rise index (>6 beats per minute)
Time frame: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
Nocturnal oxymetry measures (¢SpO2, t<90, ODI-3%, ODI-4%)
Time frame: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal
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 4 Dec 2024.
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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.
Esther I Schwarz, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous positive airway pressure (CPAP) in people with Obstructive Sleep Apnea of Adult, run by University of Zurich at 1 site in Switzerland.
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 5 inclusion and 7 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 4 Dec 2024. 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 Switzerland. 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?
Nocturnal systolic blood pressure (time frame: at baseline and at 2 and at least 8 weeks of CPAP as well as after 1 and after 2 weeks of CPAP withdrawal). The study lists 2 primary outcomes in all. 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 4 Dec 2024.