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Obstructive Sleep ApneaPhase 2NCT02220803

A Short Term Open, Randomized Cross-over Trial Exploring the Effect of Carbonic Anhydrase Inhibition by Acetazolamide on Sleep Apnea Associated Hypertension and Vascular Dysfunction

A Phase 2 study testing Acetazolamide and nasal Continuous Positive Airway Pressure (nCPAP) in people with Obstructive Sleep Apnea and Sleep-Disordered Breathing, run by Göteborg University at 1 site in Sweden.

Completed

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

Official record
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Trial summary

This is a short term open, randomized cross over trial to explore and compare the efficacy of pharmacological carbonic anhydrase (CA) inhibition on obstructive sleep apnea (OSA) related hypertension. Read more about this study

Who is it for?
Ages 18 to 75 years, men only
What is being tested?
Acetazolamide and nasal Continuous Positive Airway Pressure (nCPAP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteSweden
Study dates
Mar 2014to Aug 2016
Phase
Phase 2
Are there results?
None posted in the registry

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 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of informed consent prior to any study specific procedures
  • Males 18 to 75 years
  • An Apnea-Hypopnea Index (AHI)>15 and an Epworth Sleepiness Scale score (ESS)>6 as verified by a PSG recording.
  • Patients with established hypertension (systolic/diastolic blood pressure >= 160/95, either systolic or diastolic accounted for).
  • Clinically normal physical findings and laboratory values, as judged by the investigator
  • Body mass index >= 35 kg/m2

Who cannot join

  • Hypersensitivity to sulfonamides or acetazolamide-
  • Patients with ongoing medication with other sulphonamides or patients any specific antihypertensive treatment.
  • History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity.
  • Subjects with a seizure disorder
  • Patients with clinically verified central sleep apnea
  • Clinically significant renal (serum creatinine >2.0 mg/dL or >130 micromol/L), neurological, metabolic (e.g. Type 1 or 2 diabetes), haematological or hepatic disease (ASAT or ALAT >2 times the upper limit of normal).
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  • Subjects with an occupational risk potentially exaggerated by daytime sleepiness such as handling complex machinery or professional driving
  • Unstable angina pectoris, unstable hypertension (or poorly controlled diabetes (HbA1C < 52 mmoles/mol, or fasting plasma glucose >7 mmoles/l).
  • Clinically significant congestive heart failure.
  • Myocardial infarction or coronary vessel intervention within the previous 6 months period.
  • Subjects with uncontrolled hypertension (defined as a diastolic blood pressure ≥110 mmHg and/or a systolic blood pressure ≥180 mmHg with or without medication).
  • Previously diagnosed or treated clinically significant cardiac arrhythmia
  • Clinically significant chronic pulmonary or gastrointestinal disease.
  • Clinical history of depression as judged by the investigator or other previous or present clinically significant psychiatric disease
  • Suspected or confirmed poor compliance
  • Alcohol or drug abuse during the last year.
  • Subjects with any other significant condition that, in the opinion of the investigator, could interfere with participation in the study.
  • Severe nocturnal hypoxia defined as more than 10 episodes with an oxygen desaturation exceeding 50% or signs of lacking resaturation between desaturations on previous recordings according to investigators judgment
  • Participation in another clinical study during the last 6 months.
  • Inability to understand and complete the questionnaires.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Center for Sleep and Vigilance disorders

    Gothenburg, Västra Götaland County, 40530

Other trials in Sweden

About this study

Official title: A Short Term Open, Randomized Cross Over Trial Trial Exploring the Effect of Carbonic Anhydrase Inhibition by Acetazolamide on Sleep Apnea Associated Hypertension

This is a short term open, randomized cross over trial to explore and compare the efficacy of pharmacological carbonic anhydrase (CA) inhibition on obstructive sleep apnea (OSA) related hypertension. Patients will be randomized to receive Acetazolamide(Diamox®)(ACZ), Continuous Positive Airway Pressure (CPAP)or CPAP plus ACZ for 2 weeks. Following a 2 week wash-out period all study participants will receive the alternative treatment regimen. The total length of the study will be 10 weeks. The effects of carbonic anhydrase inhibition on blood pressure,hemodynamics and sleep apnea will be investigated.

Study hypothesis:

Carbonic anhydrase inhibition alone or in combination with nCPAP will prominently reduce blood pressure in patients with OSA. Further it is hypothesized that CA inhibition will induce a direct pharmacological effects on vascular stiffness as evidenced in overnight non-invasive assessments of vascular stiffness and that this effect will be particularly strong in patients also responding with a reduction of blood pressure.

Being tested
Acetazolamide, nasal Continuous Positive Airway Pressure (nCPAP)
Keywords
Acetazolamide, Zonegran, Obstructive Sleep apnea, Apnea, Respiration Disorders, Sleep Disorders, Cardiovascular, Hypertension, Carbonic Anhydrase, Carbonic Anhydrase Inhibitors, Enzyme Inhibitors, Sulfonamides, Therapeutic Uses, Pharmacologic Actions, Vascular stifness
Medical subject headings
Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Hypertension, Apnea, Respiration Disorders, Sleep Wake Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcetazolamideDrug

    Also called Diamox®, ATC-code: S01E C01

    Acetazolamide, 250mg tablets, will be administrated as multiple doses. Dosing of acetazolamide will be up-titrated during 3 days according to manufacturer instruction and titration scheme of the study. Maximum daily dosage is 750 mg (equivalent of 3 tablets/daily). Evening medication should be taken 2 hours before bedtime. The total length of Acetazolamide treatment will be 4 weeks (2x2) including 3 days of titration phase of the drug.

  • nasal Continuous Positive Airway Pressure (nCPAP)Device

    Also called nCPAP - Nasal Continuous Positive Airway Pressure., ResMed - S9 AutoSet™

Study groups in NCT02220803
Study groupRoleWhat they receive
Acetazolamide and CPAPActive comparatorAcetazolamide: Diamox®. Hard white capsule, 250 mg. The total treatment is 4 weeks (2+2 weeks). Dosing of acetazolamide will be up-titrated during 3 days according to manufacturer instruction and titration scheme of the study. Maximum dosage (750mg) following titration will be administered as morning (250 mg) and evening(500mg) dosages.Evening medication should be taken 2 hours before bedtime. CPAP: Continuous positive nasal airway pressure (nCPAP) delivers slightly pressurized air throughout the breathing cycle and will be given through a mask that is placed and secured over the person's nose. nCPAP titration will follow clinical routines. The standard setting is a pressure delivery in the pressure range 5-15 mbar. The adequate performance of the device is controlled by user time readers and built-in memory cards and control readings are routinely performed at the end of each treatment regimen. Total duration of CPAP treatment is 4(2+2) weeks.
Receives: Drug: Acetazolamide; Device: nasal Continuous Positive Airway Pressure (nCPAP)
CPAPActive comparatorContinuous positive nasal airway pressure (nCPAP) delivers slightly pressurized air throughout the breathing cycle and will be given through a mask that is placed and secured over the person's nose. nCPAP titration will follow clinical routines whereby the patient is equipped with an autotitrating device (Sullivan S9). The standard setting is a pressure delivery in the pressure range 5-15 mbar and the full treatment is maintained in the patient´s home. The adequate performance of the device is controlled by user time readers and built-in memory cards and control readings are routinely performed at the end of each treatment regimen. Patients will be encouraged via telephone calls for maximum use. Total duration of CPAP treatment is 4(2+2) weeks.
Receives: Device: nasal Continuous Positive Airway Pressure (nCPAP)
AcetazolamideExperimentalAcetazolamide (Diamox®) 250 mg. Hard white capsule. The total length of acetazolamide treatment will be 4 weeks (2x2) including 3 days of titration phase of the drug. Dosing of acetazolamide will be up-titrated during 3 days according to manufacturer instruction and titration scheme of the study. Maximum dosage (750mg) following titration will be administered as morning (250 mg) and evening(500mg)dosages.Evening medication should be taken 2 hours before bedtime. The tablets will be swallowed with 300 ml of water (room temperature) in an upright body position and preferably in connection to a meal.
Receives: Drug: Acetazolamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary efficacy variable is the reduction in systolic/diastolic office blood pressure (mmHg) between the treatment regimens

    The effect will be expressed in terms systolic and diastolic blood pressure (resting office, provoked office and 24 hour).

    Measured: Baseline to 10 weeks

Secondary outcomes (1)

  1. The secondary objective is to investigate the direct effect of CA inhibition on sleep disordered breathing (Apnea-hypopnea Index, AHI score (events/hour) in the subgroup of patients with OSA after treatment

    Secondary objectives include Apnea-hypopnea Index, AHI score in patients with OSA after treatment.

    Measured: Baseline to 10 weeks

Timeline

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

  1. First posted20 Aug 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02220803
Sponsor's protocol ID
CA-BP13
Other IDs
2013-004866-33
Status last verified
Aug 2016
First submitted
18 Aug 2014
Last updated
16 Aug 2016
Results posted
No

Publications

  • Eskandari D, Zou D, Grote L, Hoff E, Hedner J. Acetazolamide Reduces Blood Pressure and Sleep-Disordered Breathing in Patients With Hypertension and Obstructive Sleep Apnea: A Randomized Controlled Trial. J Clin Sleep Med. 2018 Mar 15;14(3):309-317. doi: 10.5664/jcsm.6968.

    PubMed 29510792

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Acetazolamide and nasal Continuous Positive Airway Pressure (nCPAP) in people with Obstructive Sleep Apnea and Sleep-Disordered Breathing, run by Göteborg University at 1 site in Sweden.

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 6 inclusion and 20 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 16 Aug 2016. 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 Sweden. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The primary efficacy variable is the reduction in systolic/diastolic office blood pressure (mmHg) between the treatment regimens (time frame: Baseline to 10 weeks). 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 NCT02220803, which also lists 1 linked publication.

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 16 Aug 2016.

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Clinical Trial NCT02220803 | AzTrials