Obstructive Sleep ApneaPhase 1/2NCT03858751
Pharmacological Activation of HMN for OSA Aim 2
A Phase 1/2 study testing LTM1201AZ, LTM1201AT and LTM1201AG in people with Obstructive Sleep Apnea, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- LTM1201AZ, LTM1201AT and LTM1201AG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 31 Dec 2022
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AHI > 10 events/h during NREM supine sleep
Who cannot join
- Any medical condition other than well controlled hypertension and mild diabetes.
- Any medication known to influence breathing, sleep/arousal, or muscle physiology.
- Claustrophobia.
- Inability to sleep supine.
- Allergy to any of the medications tested in the protocol.
- History of kidney stones, hypercalcemia, primary hyperparathyroidism, sarcoidosis, hypervitaminosis D.
Show all 11Show fewer
- Individuals with underlying cardiac disease, such as arrhythmias.
- Individuals taking psychiatric medications, such as an MAO-I, SSRI or SNRI, or any of the studied medications for medical care.
- For women: Pregnancy.
- Pulmonary hypertension
- Severe OSA with a mean SaO2 lower than 88%
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Nicole Calianese, Research Assistant, 617-732-8977, ncalianese@partners.org
Lauren Hess, RPSGT, 617-732-8976, lhess1@bwh.harvard.edu
About this study
Official title: Pharmacological Activation of Hypoglossal Motor Nucleus for Obstructive Sleep Apnea Aim 2
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects. In this protocol the investigators will test the effect of LTM1201AZ, LTM1201AT, LTM1201AD, LTM1201AG administered before sleep on OSA phenotype traits and OSA severity during sleep.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Placebo oral capsule, LTM1201AZ, LTM1201AT, LTM1201AG, LTM1201AD
- 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.
Placebo oral capsuleDrug
Placebo capsule before bedtime
LTM1201AZDrug
LTM1201AZ oral capsule before sleep
LTM1201ATDrug
LTM1201AT oral capsule before sleep
LTM1201AGDrug
LTM1201AG oral capsule before sleep
LTM1201ADDrug
LTM1201AD oral capsule before sleep
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo capsule before bedtime Receives: Drug: Placebo oral capsule |
| LTM1201AZ | Experimental | LTM1201AZ capsule before bedtime Receives: Drug: LTM1201AZ |
| LTM1201AT | Experimental | LTM1201AT capsule before bedtime Receives: Drug: LTM1201AT |
| LTM1201AG | Experimental | LTM1201AG capsule before bedtime Receives: Drug: LTM1201AG |
| LTM1201AD | Experimental | LTM1201AD capsule before bedtime Receives: Drug: LTM1201AD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea hypopnea Index (AHI, average number of events for every hour of sleep)
Based on previous studies the investigators anticipate that active comparators will reduce AHI more effectively in subjects with moderate sleep apnea and low-to-moderate collapsibility (Vpassive >50% of eupneic values). Higher AHI indicates more severe OSA, usually ranging between 10 to 110 events/hour.
Measured: 3 nights (treatment duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start1 Mar 2019
- Primary completion30 Nov 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
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 Brigham and Women's HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Aaron Sands, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858751
- Sponsor's protocol ID
- 2018p001201aim2
- Status last verified
- Sep 2022
- First submitted
- 27 Feb 2019
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Activation of Hypoglossal Motor Nucleus for Obstructive Sleep Apnea Aim 2
- ClinicalTrials.gov ID
- NCT03858751
- Acronym / sponsor ID
- 2018p001201aim2
- Conditions
- Obstructive Sleep Apnea
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 1 Mar 2019 (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.
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects. In this protocol the investigators will test the effect of LTM1201AZ, LTM1201AT, LTM1201AD, LTM1201AG administered before sleep on OSA phenotype traits and OSA severity during sleep.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo oral capsulePlacebo capsule before bedtime |
| LTM1201AZ | Experimental | Drug: LTM1201AZLTM1201AZ capsule before bedtime |
| LTM1201AT | Experimental | Drug: LTM1201ATLTM1201AT capsule before bedtime |
| LTM1201AG | Experimental | Drug: LTM1201AGLTM1201AG capsule before bedtime |
| LTM1201AD | Experimental | Drug: LTM1201ADLTM1201AD capsule before bedtime |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- AHI > 10 events/h during NREM supine sleep
Key exclusion criteria (11 listed)
- Any medical condition other than well controlled hypertension and mild diabetes.
- Any medication known to influence breathing, sleep/arousal, or muscle physiology.
- Claustrophobia.
- Inability to sleep supine.
- Allergy to any of the medications tested in the protocol.
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 |
|---|---|---|
| Placebo oral capsulePlacebo capsule before bedtime | Drug | Placebo |
| LTM1201AZLTM1201AZ oral capsule before sleep | Drug | LTM1201AZ |
| LTM1201ATLTM1201AT oral capsule before sleep | Drug | LTM1201AT |
| LTM1201AGLTM1201AG oral capsule before sleep | Drug | LTM1201AG |
| LTM1201ADLTM1201AD oral capsule before sleep | Drug | LTM1201AD |
Primary outcome
Apnea hypopnea Index (AHI, average number of events for every hour of sleep)
Time frame: 3 nights (treatment duration)
Based on previous studies the investigators anticipate that active comparators will reduce AHI more effectively in subjects with moderate sleep apnea and low-to-moderate collapsibility (Vpassive >50% of eupneic values). Higher AHI indicates more severe OSA, usually ranging between 10 to 110 events/hour.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LTM1201AZ, LTM1201AT and LTM1201AG in people with Obstructive Sleep Apnea, run by Brigham and Women's Hospital 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 1 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: looking for participants now, as of the sponsor's last update on 21 Sep 2022. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea hypopnea Index (AHI, average number of events for every hour of sleep) (time frame: 3 nights (treatment duration)). 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 21 Sep 2022.