Medicines taken at bedtime for obstructive sleep apnea
Tests bedtime pills versus placebo in obstructive sleep apnea.
Key facts
- Who runs it
- Brigham and Women's Hospital
- Where
- Boston, United StatesSee the site
- Trial code
- Registry title
- Pharmacological Activation of HMN for OSA Aim 2
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 16 people, planned
- Started
- 1 Mar 2019
- Planned end
- 31 Dec 2022
- Type of study
- Interventional, 5 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Placebo oral capsule
- LTM1201AZ
- LTM1201AT
- LTM1201AG
- LTM1201AD
- Record updated
- 21 September 2022
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with obstructive sleep apnea, where breathing stops often during sleep. It tests capsules taken before bedtime.
- Age
- 18 Years to 70 Years
- Sex
- All sexes can join.
- Disease stage
- Obstructive sleep apnea with AHI > 10 events/h (breathing pauses per hour) during NREM sleep while lying on the back. Severe sleep apnea with a mean SaO2 (blood oxygen) lower than 88% cannot join.
- Earlier treatment
- People taking any medicine known to affect breathing, sleep, waking or muscles cannot join. People taking psychiatric medicines such as an MAO-I, SSRI or SNRI cannot join.
- Biomarker or test result
- AHI > 10 events/h during NREM supine sleep.
Main reasons for not taking part
- Any medical condition other than well controlled high blood pressure and mild diabetes
- Heart disease such as irregular heartbeat, or pulmonary hypertension
- History of kidney stones, high calcium, primary hyperparathyroidism, sarcoidosis or too much vitamin D
- Pregnancy, fear of closed spaces, or not able to sleep on the back
- Allergy to any of the trial medicines
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- AHI > 10 events/h during NREM supine sleep
Who cannot take part
- Any medication known to influence breathing, sleep/arousal, or muscle physiology
- Any medical condition other than well controlled hypertension and mild diabetes
- Allergy to any of the medications tested in the protocol
- History of kidney stones, hypercalcemia, primary hyperparathyroidism, sarcoidosis, hypervitaminosis D
- 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
- Pulmonary hypertension
- Claustrophobia
- Inability to sleep supine
- For women: Pregnancy
- Severe OSA with a mean SaO2 lower than 88%
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Where in United States
- Brigham and Women's HospitalBoston, United StatesContact: Nicole Calianese, Research AssistantTaking people
About the trial
What the trial wants to find out
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.
The 5 groups in the trial
- PlaceboPlacebo, for comparison
Placebo capsule before bedtime
Treatment: Placebo oral capsule
- LTM1201AZTreatment being tested
LTM1201AZ capsule before bedtime
- LTM1201ATTreatment being tested
LTM1201AT capsule before bedtime
- LTM1201AGTreatment being tested
LTM1201AG capsule before bedtime
- LTM1201ADTreatment being tested
LTM1201AD capsule before bedtime
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Pharmacological Activation of Hypoglossal Motor Nucleus for Obstructive Sleep Apnea Aim 2
- Plain-language title
- Medicines taken at bedtime for obstructive sleep apneaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT03858751, who can take part
- Record updated
- 21 September 2022