Study of sulthiame combined with oral appliance therapy for patients with obstructive sleep apnea who have incomplete response to oral appliance treatment alone

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What is this study about?

This study focuses on treating patients with Obstructive Sleep Apnea who have not achieved complete improvement with oral appliance therapy alone. The research examines the effectiveness of combining an oral appliance with sulthiame, a medication that works by inhibiting an enzyme called carbonic anhydrase in the body.

The purpose of this research is to determine if adding sulthiame to existing oral appliance therapy can help improve breathing during sleep in people whose symptoms are not fully controlled by the oral appliance alone. During the study, participants will receive either sulthiame or placebo while continuing to use their oral appliance. The medication will be given as film-coated tablets, with a daily dose of up to 200 mg.

The study will use a crossover design, meaning that participants will receive both sulthiame and placebo at different times during the research period. Each treatment period will last for two weeks. Throughout the study, participants will undergo sleep studies to measure their breathing patterns during sleep and complete questionnaires about their daytime functioning and quality of life.

1 Initial sleep study

You will undergo an overnight polysomnography (PSG) – a detailed sleep study that monitors your breathing patterns, oxygen levels, and sleep quality while using your oral appliance.

This test will confirm if you have an apnea/hypopnea index (AHI) of 15 or higher while using the oral appliance, which indicates incomplete response to treatment.

2 Treatment phase 1

You will receive either sultiame (Ospolot) tablets or placebo tablets for 2 weeks.

The medication (or placebo) should be taken by mouth daily.

During this period, you will continue using your oral appliance for sleep.

3 Second sleep study

After the first 2-week period, you will undergo another overnight sleep study while using both the oral appliance and the study medication.

4 Treatment phase 2

You will switch to the other treatment (either sultiame or placebo, opposite of what you received in phase 1) for another 2 weeks.

Continue using your oral appliance during sleep.

5 Final sleep study

After the second 2-week period, you will undergo a final overnight sleep study while using both the oral appliance and the study medication.

Various measurements will be taken, including oxygen levels during sleep, sleep stages, and breathing patterns.

6 Health assessments

Throughout the study, various health measurements will be taken, including blood pressure and blood tests.

You will complete questionnaires about your sleep quality, daytime functioning, and general well-being.

Who Can Join the Study?

You must have sleep apnea (a condition where breathing repeatedly stops during sleep) that is not fully controlled with oral device therapy
Your AHI score (Apnea-Hypopnea Index, which measures how many times per hour your breathing stops or becomes very shallow during sleep) must be 15 or higher
You must be able to understand and sign an informed consent form after receiving a full explanation of the study
You must be able to:
- Speak and read in the local language
- Answer questions
- Follow instructions
- Fill out questionnaires
- Follow study procedures
You must be between 18 and 75 years old
You can be either male or female

Who Cannot Join the Study?

Current diagnosis of severe sleep apnea (a condition where breathing repeatedly stops and starts during sleep)
Known allergy or sensitivity to sulthiam or similar medications
History of kidney stones or severe kidney problems
Pregnancy or breastfeeding
Significant liver disease or abnormal liver function tests
Uncontrolled high blood pressure
History of seizures or epilepsy
Current use of medications that might interact with the study drug
Mental health conditions that could affect ability to comply with study requirements
Participation in another clinical trial within the past 30 days
History of substance abuse within the past year
Severe heart, lung, or neurological conditions
Unable or unwilling to follow study procedures
Work schedule that involves regular night shifts
Use of other medications for sleep apnea treatment

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Region Sjaelland	Holbæk	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.09.2024
Sweden	Not recruiting	01.09.2024

Trial locations

Investigated drugs:

Sultiame

Sulthiame is a carbonic anhydrase inhibitor medication used to treat certain types of seizures. In this trial, it is being studied as a potential treatment for obstructive sleep apnea in combination with oral appliance therapy. The medication works by affecting certain enzymes in the body that may influence breathing patterns during sleep.

Oral Appliance Therapy (OAT) is a dental device worn in the mouth during sleep. It helps keep the airway open by holding the lower jaw in a forward position, which can reduce or prevent airway collapse that causes sleep apnea. This device is similar to a mouthguard and is custom-fitted to each patient’s mouth.

Obstructive Sleep Apnea (OSA) – A sleep disorder characterized by repeated episodes of complete or partial blockage of the upper airway during sleep. During these episodes, the airway muscles temporarily relax and collapse, leading to pauses in breathing that typically last between 10 to 30 seconds. These breathing interruptions can occur many times throughout the night, causing oxygen levels in the blood to drop. The condition often causes fragmented sleep as the brain briefly wakes the person to resume breathing. Common signs include loud snoring, gasping for air during sleep, morning headaches, and daytime sleepiness. The severity can range from mild to severe, depending on how often breathing is interrupted during sleep.

Trial ID:

2023-510519-20-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of sulthiame combined with oral appliance therapy for patients with obstructive sleep apnea who have incomplete response to oral appliance treatment alone

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?