Obstructive Sleep Apnea study: IHL-42X:
Official title DReAMzz- Dronabinol and Acetazolamide Medication for Sleep Apnea (ZZ). Dose Confirmation Crossover Study for IHL-42X in Subjects With Obstructive Sleep Apnea.
ClinicalTrials.gov ID: NCT07635563
What this study is testing
What is IHL-42X?
an investigational oral medication being studied as a potential treatment for obstructive sleep apnea is designed to stimulate breathing by causing mild metabolic acidosis through acetazolamide’s carbonic anhydrase inhibition
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to learn whether IHL‑42X is safe and works to reduce sleep apnea severity, and to pick the best dose.
- Who it's for
- Adults who have been diagnosed with obstructive sleep apnea.
- What's involved
- Participants will take the study medication (or placebo) in several 28‑day periods, not knowing which they receive, and will have sleep studies and safety check‑ups at each visit.
- Time commitment
- The trial lasts about 12 weeks, with clinic visits at the start of each 4‑week treatment period and follow‑up assessments.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Aged ≥18 and ≤65 years of age at the time of consent.
- AHI4 ≥5
- ≤25% central or mixed apneas out of total AHI
- no Cheyne-Stokes respiration
- total sleep time ≥ 4 hours in each PSG
You likely can't join if
- Body mass index (BMI) \>40 kg/m2 (men) and \>42 kg/m2 (women).
- Diagnosed obesity hypoventilation syndrome or hypercapnia.
- PAP-compliant, defined by use of PAP for ≥4 hours for at least 63 nights during the consecutive 90-day period.
- Current use of custom-made oral appliances (mandibular advancement device, tongue retaining device, or mouth guard) or hypoglossal nerve stimulation...
- Maxillomandibular advancement, upper airway, or bariatric surgery within the last 6 months prior to first administration of the study drug
- Have commenced glucagon-like peptide-1 receptor agonist therapy within the last 6 months.
See the full eligibility criteria
- Aged ≥18 and ≤65 years of age at the time of consent.
- AHI4 ≥5
- ≤25% central or mixed apneas out of total AHI
- no Cheyne-Stokes respiration
- total sleep time ≥ 4 hours in each PSG
- \< 30 periodic leg movement disorder arousals per hour.
- A difference in AHI4 of ≤15 between screening PSG 1 and screening PSG 2.
- A PROMIS-SRI 8a score of \>16.
- Participants are regarded as PAP-non-compliant if they do not use PAP for ≥ 4 hours for at least 63 nights during consecutive 90-day period based on data collected from the PAP device (e.g., SD storage cards) and/or a...
- Participants are regarded as PAP-intolerant if they are former PAP users, i.e., a PAP device that they have not used for \>90 days, have tried PAP and not continued to use it or refusal of PAP after prior positive sleep...
- Must agree not to take any form of cannabis or cannabinoid with the exception of the IP, or any other illicit or recreational drug while participating in this study.
- Intra-uterine device in place for at least 3 months prior to Day 1 through to 10 days following the last dose of the study drug.
- 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels \> 40 mIU/ml.
- Undergone bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 6 months prior to Day 1.
- Barrier method (condom) from date of consent through to 10 days after the final dose of the study drug.
- Surgical sterilization (vasectomy) at least 6 months prior to Day 1 with proof of azoospermia.
- Voluntarily written consent to participate in the study and be willing and able to participate in all scheduled visits, treatment plans, tests, and other study procedures according to the protocol.
- Body mass index (BMI) \>40 kg/m2 (men) and \>42 kg/m2 (women).
- Diagnosed obesity hypoventilation syndrome or hypercapnia.
- PAP-compliant, defined by use of PAP for ≥4 hours for at least 63 nights during the consecutive 90-day period.
- Current use of custom-made oral appliances (mandibular advancement device, tongue retaining device, or mouth guard) or hypoglossal nerve stimulation devices. Devices must not be used for the duration of the study.
- Maxillomandibular advancement, upper airway, or bariatric surgery within the last 6 months prior to first administration of the study drug; or participants who are planning surgical treatment.
- Have commenced glucagon-like peptide-1 receptor agonist therapy within the last 6 months.
- Use of benzodiazepines, sedative-hypnotics or stimulants (Anatomical Therapeutic Chemical [ATC] N06B, N05C, N05BA, N03AE, and N01AF categories) to treat insomnia, OSA, and other sleep disorders, or other disorders that...
- Use of other prescription medications to treat insomnia.
- Pierre Robin, Treacher Collins, or other craniofacial malformation syndrome, or grade ≥3 tonsillar hypertrophy.
- Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
- Known allergic or other severe reaction to cannabis products with previous use.
- Known allergic reaction to sesame oil.
- Known allergic reaction to acetazolamide.
- Pregnant or breastfeeding.
- Current illicit drug abuse (within the last 6 months prior to screening); "abuse" has some subsets that are objective and some that require investigator judgement
- An objective subset includes consumption of substances that are "illicit", i.e., not legal per local laws
- Investigator judgement is expected for legally marketed products ingested for other than the approved indication(s)
- Participants who test positive to THC should be screen failed and can be considered for rescreening after a \>6-week washout period. Participants can only be rescreened once.
- Severe depression, defined as a score of ≥30 on the Major Depression Inventory (MDI) questionnaire.
- Severe anxiety, defined as score of \>15 on the General Anxiety Disorder-7 (GAD-7) questionnaire.
- Severe psychiatric disorder that might be aggravated or exacerbated by dronabinol's potential to cause anxiety/nervousness, depersonalization, hallucination, etc.
- Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
- Cardiac dysfunction and/or its treatment that might augment dronabinol's potential to cause tachycardia or vasodilation.
- Marked hepatic dysfunction as defined by elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 × the upper limit of normal (ULN), that would reduce dronabinol metabolism. i.
- Known CYP2C9 poor metabolizers (NB: this is based on medical history and does not need to be tested genetically).
- Other ongoing condition(s) that the investigator considers may be clinically significant with regards to the participant's safe participation in this study or may confound this study's findings
- Shift workers whose shift pattern has the potential to disrupt sleep patterns.
- Participation in any other treatment studies involving investigational or marketed products within 30 days or 5.5 half-lives, whichever is longer, prior to screening.
The study team makes the final eligibility decision.
Where it is enrolling
- Chula Vista, California, United States
- Brandon, Florida, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- West Palm Beach, Florida, United States
- Rockville, Maryland, United States
- Cincinnati, Ohio, United States
- Anderson, South Carolina, United States
- Memphis, Tennessee, United States
- Dallas, Texas, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chula Vista, California, United States; Brandon, Florida, United States; Jacksonville, Florida, United States; Orlando, Florida, United States; West Palm Beach, Florida, United States; Rockville, Maryland, United States and 5 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.