Obstructive Sleep ApneaPhase 1/2OSA12NCT03640052

Pharmacological Activation of HMN for OSA

A Phase 1/2 study testing LTM1201L, LTM1201LN and LTM1201LB in people with Obstructive Sleep Apnea, run by Brigham and Women's Hospital at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Obstructive Sleep Apnea
What is being tested?: LTM1201L, LTM1201LN and LTM1201LB
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 6 participants
Where: 2 sitesUnited States
Study dates: 30 Oct 2018to 31 Dec 2019
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

2 sites in 1 country.

United States2 sites

Brigham and Women's Hospital
Boston, Massachusetts, 02115
Sleep Disorders Research Program Brigham and Women's Hospital
Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Pharmacological Activation of Hypoglossal Motor Nucleus for Obstructive Sleep Apnea

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 LTM1201L, LTM1201LN, LTM1201LB, LTM1201LD administered before sleep on OSA phenotype traits and OSA severity during sleep.

Conditions: Obstructive Sleep Apnea
Being tested: Placebo oral capsule, LTM1201L, LTM1201LN, LTM1201LB, LTM1201LD
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 sleep
LTM1201LDrug
LTM1201L capsule before sleep
LTM1201LNDrug
LTM1201LN capsule before sleep
LTM1201LBDrug
LTM1201LB capsule before sleep
LTM1201LDDrug
LTM1201LD capsule before sleep

Study groups in NCT03640052
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo capsule 1 time before bedtime Receives: Drug: Placebo oral capsule
LTM1201L	Active comparator	LTM1201L capsule 1 time before bedtime Receives: Drug: LTM1201L
LTM1201LN	Active comparator	LTM1201LN capsule 1 time before bedtime Receives: Drug: LTM1201LN
LTM1201LB	Active comparator	LTM1201LB capsule 1 time before bedtime Receives: Drug: LTM1201LB
LTM1201LD	Active comparator	LTM1201LD capsule 1 time before bedtime Receives: Drug: LTM1201LD

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: 1 night

Secondary outcomes (1)

Collapsibility of the Upper Airway: VActive (L/Min)
VActive: ventilation when ventilatory drive is high and pharyngeal dilator muscles are relatively active.
Measured: 1 night

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Oct 201831 Dec 2019

First posted21 Aug 2018
Study start30 Oct 2018
Primary completion30 Sep 2019
Study completion31 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03640052
Sponsor's protocol ID: 2018P001201
Acronym: OSA12
Status last verified: Feb 2020
First submitted: 17 Aug 2018
Last updated: 24 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2020. 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
ClinicalTrials.gov ID: NCT03640052
Acronym / sponsor ID: OSA12 / 2018P001201
Conditions: Obstructive Sleep Apnea
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Brigham and Women's HospitalUniversity, hospital or other
Study start: 30 Oct 2018 (actual)
Primary completion: 30 Sep 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 21 Aug 2018 (actual)
Results: Posted 24 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo oral capsulePlacebo capsule 1 time before bedtime
LTM1201L	Active comparator	Drug: LTM1201LLTM1201L capsule 1 time before bedtime
LTM1201LN	Active comparator	Drug: LTM1201LNLTM1201LN capsule 1 time before bedtime
LTM1201LB	Active comparator	Drug: LTM1201LBLTM1201LB capsule 1 time before bedtime
LTM1201LD	Active comparator	Drug: LTM1201LDLTM1201LD capsule 1 time 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 sleep	Drug	Placebo
LTM1201LLTM1201L capsule before sleep	Drug	LTM1201L
LTM1201LNLTM1201LN capsule before sleep	Drug	LTM1201LN
LTM1201LBLTM1201LB capsule before sleep	Drug	LTM1201LB
LTM1201LDLTM1201LD capsule before sleep	Drug	LTM1201LD

Primary outcome

Apnea Hypopnea Index (AHI, Average Number of Events for Every Hour of Sleep)
Time frame: 1 night
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.

1 secondary outcome

Collapsibility of the Upper Airway: VActive (L/Min)
Time frame: 1 night

Results and safety

Results posted to the registry on 24 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo First	2	2
LTM1201L First	1	0
LTM1201LD First	1	1
LTM1201LN First	1	1
LTM1201LB First	1	1

Primary outcome: Apnea Hypopnea Index (AHI, Average Number of Events for Every Hour of Sleep)

Time frame: 1 night. Mean (Standard Error). Unit: events/hour of sleep

Measure	Placebo n = 6	LTM1201L n = 6	LTM1201LN n = 6	LTM1201LB n = 5	LTM1201LD n = 6
Value	20.8 (8)	24.4 (11.3)	18.8 (11.3)	14 (11.3)	9.1 (11.9)

LTM1201L: Mean Difference (Final Values): 3.6, p >0.5, Mixed Models Analysis
LTM1201LN: Mean Difference (Net): -2, p >0.5, Mixed Models Analysis
LTM1201LB: Mean Difference (Net): -6.8, p >0.5, Mixed Models Analysis

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 night. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 6 (0%)	3 of 6 (50%)	0 of 6
LTM1201L	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
LTM1201LN	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
LTM1201LB	0 of 6 (0%)	3 of 5 (60%)	0 of 6
LTM1201LD	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites 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 LTM1201L, LTM1201LN and LTM1201LB in people with Obstructive Sleep Apnea, run by Brigham and Women's Hospital at 2 sites 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: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 24 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Apnea Hypopnea Index (AHI, Average Number of Events for Every Hour of Sleep) (time frame: 1 night). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03640052.

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 24 Feb 2020.