Obstructive Sleep ApneaNCT02484300
The Effect of Melatonin on Sleep and Ventilatory Control in Obstructive Sleep Apnea
A study testing Melatonin in people with Obstructive Sleep Apnea, run by University of California, San Diego at 1 site in United States.
Trial summary
Our hypothesis is that oxidative stress induced during repeated apneas in obstructive sleep apnea (OSA) patients alters the neural control of breathing which destabilizes ventilatory control and exacerbates OSA. Thus antioxidant treatment has the potential to reduce OSA severity. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Melatonin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Nov 2017
- 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 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male
- Ages 18-70 years
- No other sleep disorders
- Severe OSA (≥30 apnea hypopnea index)
Who cannot join
- Females
- Smokers (quit ≥ 1 year ago acceptable)
- Abnormal lung function (FEV1 and FVC < 80% predicted)
- Any known cardiac (apart from treated hypertension with acceptable drugs, see below), pulmonary (including asthma), renal, neurologic (including epilepsy), neuromuscular, hepatic disease, or patients with diabetes.
- History of driving or other accidents due to sleepiness or an ESS > 18.
- Prior or current use of melatonin.
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- Use of serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, ACE inhibitors or any drugs which interfere with the renin-Angiotensin system, Losartan (or other Angiotensin II type 1 receptor antagonists), non-specific calcium channel blockers (L channel specific are acceptable), anti-inflammatories, vitamins or any antioxidants.
- Use of any medications that may affect sleep or breathing.
- A psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders.
- Substantial alcohol (>3oz/day) or use of illicit drugs.
- More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
San Diego, California, 92093
About this study
Our hypothesis is that oxidative stress induced during repeated apneas in obstructive sleep apnea (OSA) patients alters the neural control of breathing which destabilizes ventilatory control and exacerbates OSA. Thus antioxidant treatment has the potential to reduce OSA severity. Melatonin is a hormone which regulates sleep patterns, but it is also a potent antioxidant. Melatonin production is suppressed when the eyes register light so people with healthy sleep exhibit a peak in blood serum levels around 2am which then decreases towards morning. OSA patients exhibit lower melatonin levels with a later peak around 6am which then extends later into the day. This abnormal pattern is thought to compound difficulty falling asleep and daytime mental fatigue. Therefore the potential benefits of melatonin treatment in OSA patients are two-fold: most importantly via its antioxidant actions melatonin may reduce chemoreflex sensitivity, stabilize ventilatory control and reduce OSA severity; by normalizing sleep phase melatonin may also allow patients to fall asleep easier and wake more refreshed.
Read the detailed description
OSA is a common sleep disorder characterized by repeated collapse of the upper airway during sleep causing bouts of hypercapnia and hypoxia, typically followed by arousal, hyperventilation and a subsequent apnea. The resultant swings in blood gases and fragmented sleep have been associated with major neurocognitive and cardiovascular sequelae. Although the commonly cited statistics are that 4% of middle aged US men and 2% of US women have symptomatic OSA, these figures may be underestimates. However despite its prevalence and well recognized consequences, treatment of OSA remains unacceptable due to poor adherence to and variable efficacy of existing therapies, leading many to advocate for further research into underlying mechanisms to identify new therapeutic targets.
During sleep ventilatory control is dominated by the level of CO2 and O2 in the blood. Arterial CO2 has the greatest influence, with increasing CO2 stimulating an increase in ventilatory drive and vice versa. Ventilatory drive not only determines the level of activity of the thoracic pump muscles, but also the upper airway dilator muscles. Consequently the upper airway is susceptible to collapse when CO2, and therefore neural drive to the upper airway muscles, is low. Loop gain is an engineering method used to measure the stability of the negative feedback chemoreflex control system, calculated as the ratio of the ventilatory response to the disturbance which elicited the response. Higher LG equals less stable control, as a disproportionately large ventilatory response will result in a greater degree of hypocapnia and subsequent reduction in ventilatory drive. Thus high LG contributes to propagating apneas. Supporting this is evidence that OSA patients have higher LG than non-OSA and LG correlates with the apnea hypopnea index (AHI). Additionally, treatments such as supplemental oxygen and acetazolamide which reduce LG significantly reduce AHI. However these treatments essentially counteract high LG, rather than treating the cause of high LG.
LG includes "plant" (respiratory apparatus) and "controller" (chemoreflex) gain components. OSA patients exhibit abnormalities in chemoreflex control which increase the sensitivity to blood gases and thus increase controller and LG. These abnormalities normalize with continuous positive airway pressure (CPAP) treatment, indicating they are induced by OSA itself. Intermittent hypoxia, as occurs during repeated apneas, induces lasting changes in the neural control of breathing which induces the same abnormalities and increased controller gain as is seen in OSA. Therefore it is thought that the IH experienced in OSA contributes to worsening of OSA by inducing changes to the neural control of breathing which increase controller and LG. The cellular changes induced by IH are dependent on the formation of reactive oxygen species (ROS) and both animal and human studies have shown antioxidant treatment prior to IH experimentally blocks these neural changes. Thus antioxidants may be a suitable alternative treatment in OSA, by treating the actual cause of high LG. Indeed there have been two published studies showing vitamins and N-acetyl-cysteine reduced AHI in OSA patients.
Melatonin is a hormone produced in the pineal gland of the brain which is most well-known for its critical role in regulating sleep and the circadian clock. However it is also a potent antioxidant which not only acts as a direct free radical scavenger, but it also stimulates synthesis of other antioxidants. Unlike most antioxidants it also crosses all cell membranes easily, allowing it to cross the blood brain barrier and also enter intracellular compartments such as mitochondria where ROS production is highest. Owing to the fact that most antioxidants become reactive species themselves once they have been oxidized, many antioxidants become toxic and cause disease with prolonged high doses. For this reason most antioxidants are unsuitable as a long-term treatment option in OSA. However melatonin does not have this problem because as it is oxidized it converts into multiple different metabolites all of which have various antioxidant functions. This adds to its efficacy as it neutralizes an extremely wide range of radical species. Consequently melatonin is non-toxic at even extremely high doses and extended use. Indeed melatonin has been found effective in treating multiple diseases in humans associated with ROS and oxidative stress, such as diabetes, chronic obstructive pulmonary disease and multiple sclerosis. Of particular interest is that OSA is intimately associated with metabolic disorder, with the two conditions having compounding negative consequences on cardiovascular disease, and melatonin has been shown to improve hypertension, oxidative stress and blood lipid profiles in metabolic disorder. For these reasons, we propose that melatonin may be a safe long term treatment option in OSA patients that are unable to tolerate CPAP, which may block the neural changes induced by IH, thereby reducing controller and LG and therefore reducing AHI. Additionally, melatonin treatment may have added benefits associated with preventing ROS induced morbidities of both OSA and metabolic disorder.
Melatonin production is inhibited by light and normally peaks around 2am. However OSA exhibit much lower levels of melatonin with a lower peak at around 6am. OSA is associated with chronic systemic oxidative stress and endogenous levels of melatonin play a critical role in regulation of total antioxidant status. Therefore this abnormal pattern of melatonin production in OSA likely contributes to exacerbation of oxidative stress and also to sleep and cognitive deficits in OSA, as this would delay the circadian sleep phase, making it difficult for patients to fall asleep and adding to mental fatigue during the morning. Therefore, in addition to its antioxidant activity, melatonin treatment in OSA may have additional benefits via normalizing sleep phase. Thus the primary focus of this study will be to investigate the effects of melatonin treatment in OSA on waking chemoreflex control and ventilatory stability as assessed via LG and AHI during sleep, but we also intend to assess if there are additional sleep and cardiovascular benefits of melatonin treatment, by assessing melatonin blood serum phase resetting effects, sleep quality, blood pressure and electrocardiogram (ECG).
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Melatonin, Placebo
- Keywords
- loop gain, chemoreflex control, melatonin, antioxidant, obstructive sleep apnea, ventilatory control
- 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.
MelatoninDietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Melatonin 4hrs before bed | Experimental | Time of dosage comparison on blood serum melatonin phase and subjective sleepiness Receives: Dietary Supplement: Melatonin |
| Melatonin 2hrs before bed | Experimental | Time of dosage comparison on blood serum melatonin phase and subjective sleepiness Receives: Dietary Supplement: Melatonin |
| Melatonin | Experimental | To determine effects of 10mg daily melatonin on chemoreflex control, oxidation status, loop gain and apnea hypopnea index in obstructive sleep apnea Receives: Dietary Supplement: Melatonin |
| Placebo | Placebo comparator | Placebo outcomes versus melatonin Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in hypercapnic and hypoxic ventilatory response tests after one month of melatonin
modified rebreathing tests will be utilised to assess the entire chemoreflex range
Measured: baseline and after one month of either melatonin or placebo
change from baseline in apnea hypopnea index after one month of melatonin
assess using standard sleep scoring criteria
Measured: baseline and after one month of either melatonin or placebo
change from baseline in loop gain after one month of melatonin
assessed using flow from standard sleep study with method by Terrill (2014)
Measured: baseline and after one month of either melatonin or placebo
change from baseline in blood serum oxidative markers after one month of melatonin
comparison of blood serum Angiotensin II, total glutathione, oxidized/reduced glutathione ratio, glutathione peroxidase, super oxide dismutase, C-Reactive protein, catalase pre and post treatment
Measured: baseline and after one month of either melatonin or placebo
change from baseline in blood serum melatonin concentration after one week of melatonin
assessed 2 hourly from 10pm to 6am to determine onset, peak and offset and phase resetting
Measured: baseline and after one week daily 10mg melatonin either 4hrs or 2hrs before bed
Secondary outcomes (3)
change from baseline in mean arterial blood pressure after one month of melatonin
Measured: baseline and after one month of either melatonin or placebo
change from baseline in Epworth Sleepiness Score after one week of melatonin
To compare subjective daytime sleepiness following 1 week melatonin use versus baseline
Measured: baseline and after one week daily 10mg melatonin either 4hrs or 2hrs before bed
change from baseline in actigraphy watch data and sleep diary entries after one week of melatonin
To compare potential changes in sleep patterns and activity at home
Measured: one week baseline behaviour and one week of melatonin treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Robert L. Owens, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484300
- Sponsor's protocol ID
- 150465
- Other IDs
- R01HL085188
- Status last verified
- Dec 2020
- First submitted
- 19 Jun 2015
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Melatonin on Sleep and Ventilatory Control in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02484300
- Acronym / sponsor ID
- 150465
- Conditions
- Obstructive Sleep Apnea
- Keywords
- loop gain, chemoreflex control, melatonin, antioxidant, obstructive sleep apnea, ventilatory control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2015 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 29 Jun 2015 (estimated)
- 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.
Our hypothesis is that oxidative stress induced during repeated apneas in obstructive sleep apnea (OSA) patients alters the neural control of breathing which destabilizes ventilatory control and exacerbates OSA. Thus antioxidant treatment has the potential to reduce OSA severity. Melatonin is a hormone which regulates sleep patterns, but it is also a potent antioxidant. Melatonin production is suppressed when the eyes register light so people with healthy sleep exhibit a peak in blood serum levels around 2am which then decreases towards morning. OSA patients exhibit lower melatonin levels with a later peak around 6am which then extends later into the day. This abnormal pattern is thought to compound difficulty falling asleep and daytime mental fatigue. Therefore the potential benefits of melatonin treatment in OSA patients are two-fold: most importantly via its antioxidant actions melatonin may reduce chemoreflex sensitivity, stabilize ventilatory control and reduce OSA severity; by normalizing sleep phase melatonin may also allow patients to fall asleep easier and wake more refreshed.
Detailed description
OSA is a common sleep disorder characterized by repeated collapse of the upper airway during sleep causing bouts of hypercapnia and hypoxia, typically followed by arousal, hyperventilation and a subsequent apnea. The resultant swings in blood gases and fragmented sleep have been associated with major neurocognitive and cardiovascular sequelae. Although the commonly cited statistics are that 4% of middle aged US men and 2% of US women have symptomatic OSA, these figures may be underestimates. However despite its prevalence and well recognized consequences, treatment of OSA remains unacceptable due to poor adherence to and variable efficacy of existing therapies, leading many to advocate for further research into underlying mechanisms to identify new therapeutic targets.
During sleep ventilatory control is dominated by the level of CO2 and O2 in the blood. Arterial CO2 has the greatest influence, with increasing CO2 stimulating an increase in ventilatory drive and vice versa. Ventilatory drive not only determines the level of activity of the thoracic pump muscles, but also the upper airway dilator muscles. Consequently the upper airway is susceptible to collapse when CO2, and therefore neural drive to the upper airway muscles, is low. Loop gain is an engineering method used to measure the stability of the negative feedback chemoreflex control system, calculated as the ratio of the ventilatory response to the disturbance which elicited the response. Higher LG equals less stable control, as a disproportionately large ventilatory response will result in a greater degree of hypocapnia and subsequent reduction in ventilatory drive. Thus high LG contributes to propagating apneas. Supporting this is evidence that OSA patients have higher LG than non-OSA and LG correlates with the apnea hypopnea index (AHI). Additionally, treatments such as supplemental oxygen and acetazolamide which reduce LG significantly reduce AHI. However these treatments essentially counteract high LG, rather than treating the cause of high LG.
LG includes "plant" (respiratory apparatus) and "controller" (chemoreflex) gain components. OSA patients exhibit abnormalities in chemoreflex control which increase the sensitivity to blood gases and thus increase controller and LG. These abnormalities normalize with continuous positive airway pressure (CPAP) treatment, indicating they are induced by OSA itself. Intermittent hypoxia, as occurs during repeated apneas, induces lasting changes in the neural control of breathing which induces the same abnormalities and increased controller gain as is seen in OSA. Therefore it is thought that the IH experienced in OSA contributes to worsening of OSA by inducing changes to the neural control of breathing which increase controller and LG. The cellular changes induced by IH are dependent on the formation of reactive oxygen species (ROS) and both animal and human studies have shown antioxidant treatment prior to IH experimentally blocks these neural changes. Thus antioxidants may be a suitable alternative treatment in OSA, by treating the actual cause of high LG. Indeed there have been two published studies showing vitamins and N-acetyl-cysteine reduced AHI in OSA patients.
Melatonin is a hormone produced in the pineal gland of the brain which is most well-known for its critical role in regulating sleep and the circadian clock. However it is also a potent antioxidant which not only acts as a direct free radical scavenger, but it also stimulates synthesis of other antioxidants. Unlike most antioxidants it also crosses all cell membranes easily, allowing it to cross the blood brain barrier and also enter intracellular compartments such as mitochondria where ROS production is highest. Owing to the fact that most antioxidants become reactive species themselves once they have been oxidized, many antioxidants become toxic and cause disease with prolonged high doses. For this reason most antioxidants are unsuitable as a long-term treatment option in OSA. However melatonin does not have this problem because as it is oxidized it converts into multiple different metabolites all of which have various antioxidant functions. This adds to its efficacy as it neutralizes an extremely wide range of radical species. Consequently melatonin is non-toxic at even extremely high doses and extended use. Indeed melatonin has been found effective in treating multiple diseases in humans associated with ROS and oxidative stress, such as diabetes, chronic obstructive pulmonary disease and multiple sclerosis. Of particular interest is that OSA is intimately associated with metabolic disorder, with the two conditions having compounding negative consequences on cardiovascular disease, and melatonin has been shown to improve hypertension, oxidative stress and blood lipid profiles in metabolic disorder. For these reasons, we propose that melatonin may be a safe long term treatment option in OSA patients that are unable to tolerate CPAP, which may block the neural changes induced by IH, thereby reducing controller and LG and therefore reducing AHI. Additionally, melatonin treatment may have added benefits associated with preventing ROS induced morbidities of both OSA and metabolic disorder.
Melatonin production is inhibited by light and normally peaks around 2am. However OSA exhibit much lower levels of melatonin with a lower peak at around 6am. OSA is associated with chronic systemic oxidative stress and endogenous levels of melatonin play a critical role in regulation of total antioxidant status. Therefore this abnormal pattern of melatonin production in OSA likely contributes to exacerbation of oxidative stress and also to sleep and cognitive deficits in OSA, as this would delay the circadian sleep phase, making it difficult for patients to fall asleep and adding to mental fatigue during the morning. Therefore, in addition to its antioxidant activity, melatonin treatment in OSA may have additional benefits via normalizing sleep phase. Thus the primary focus of this study will be to investigate the effects of melatonin treatment in OSA on waking chemoreflex control and ventilatory stability as assessed via LG and AHI during sleep, but we also intend to assess if there are additional sleep and cardiovascular benefits of melatonin treatment, by assessing melatonin blood serum phase resetting effects, sleep quality, blood pressure and electrocardiogram (ECG).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Melatonin 4hrs before bed | Experimental | Dietary Supplement: MelatoninTime of dosage comparison on blood serum melatonin phase and subjective sleepiness |
| Melatonin 2hrs before bed | Experimental | Dietary Supplement: MelatoninTime of dosage comparison on blood serum melatonin phase and subjective sleepiness |
| Melatonin | Experimental | Dietary Supplement: MelatoninTo determine effects of 10mg daily melatonin on chemoreflex control, oxidation status, loop gain and apnea hypopnea index in obstructive sleep apnea |
| Placebo | Placebo comparator | Other: PlaceboPlacebo outcomes versus melatonin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male
- Ages 18-70 years
- No other sleep disorders
- Severe OSA (≥30 apnea hypopnea index)
Key exclusion criteria (11 listed)
- Females
- Smokers (quit ≥ 1 year ago acceptable)
- Abnormal lung function (FEV1 and FVC < 80% predicted)
- Any known cardiac (apart from treated hypertension with acceptable drugs, see below), pulmonary (including asthma), renal, neurologic (including epilepsy), neuromuscular, hepatic disease, or patients with diabetes.
- History of driving or other accidents due to sleepiness or an ESS > 18.
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 |
|---|---|---|
| Melatonin | Dietary supplement | Melatonin, Melatonin 2hrs before bed, Melatonin 4hrs before bed |
| Placebo | Other | Placebo |
Primary outcome
change from baseline in hypercapnic and hypoxic ventilatory response tests after one month of melatonin
Time frame: baseline and after one month of either melatonin or placebo
modified rebreathing tests will be utilised to assess the entire chemoreflex range
change from baseline in apnea hypopnea index after one month of melatonin
Time frame: baseline and after one month of either melatonin or placebo
assess using standard sleep scoring criteria
change from baseline in loop gain after one month of melatonin
Time frame: baseline and after one month of either melatonin or placebo
assessed using flow from standard sleep study with method by Terrill (2014)
change from baseline in blood serum oxidative markers after one month of melatonin
Time frame: baseline and after one month of either melatonin or placebo
comparison of blood serum Angiotensin II, total glutathione, oxidized/reduced glutathione ratio, glutathione peroxidase, super oxide dismutase, C-Reactive protein, catalase pre and post treatment
change from baseline in blood serum melatonin concentration after one week of melatonin
Time frame: baseline and after one week daily 10mg melatonin either 4hrs or 2hrs before bed
assessed 2 hourly from 10pm to 6am to determine onset, peak and offset and phase resetting
3 secondary outcomes
change from baseline in mean arterial blood pressure after one month of melatonin
Time frame: baseline and after one month of either melatonin or placebo
change from baseline in Epworth Sleepiness Score after one week of melatonin
Time frame: baseline and after one week daily 10mg melatonin either 4hrs or 2hrs before bed
change from baseline in actigraphy watch data and sleep diary entries after one week of melatonin
Time frame: one week baseline behaviour and one week of melatonin treatment
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 22 Dec 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin in people with Obstructive Sleep Apnea, run by University of California, San Diego at 1 site in United States.
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 11 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 22 Dec 2020. 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 United States. 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.
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?
change from baseline in hypercapnic and hypoxic ventilatory response tests after one month of melatonin (time frame: baseline and after one month of either melatonin or placebo). The study lists 5 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 22 Dec 2020.