A Phase 4 interventional study of Acetazolamide and Placebo in Obstructive Sleep Apnea, sponsored by University Hospital, Antwerp. Status unknown at 1 site in Belgium. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-18.
Sponsored by University Hospital, Antwerp · Phase 4, Interventional, and Treatment
Surgical procedures are routinely performed as an alternative to continuous positive airway pressure treatment in patients with obstructive sleep apnea (OSA). However, the response to surgery is often variable. Instability of the respiratory control during sleep (or high loop gain) has been associated with poor surgical results in previous research. Acetazolamide (AZM), a carbonic anhydrase inhibitor, has shown potential in reducing loop gain without affecting other physiological OSA traits. In this protocol the investigators will evaluate the clinical efficacy of AZM add-on therapy to surgical procedures in patients with OSA.
Seventy-four patients with diagnosed moderate to severe OSA will be equally (1:1) randomized to AZM (250 mg twice daily) or placebo add-on therapy after surgery. Two surgical procedures will be performed throughout the study: barbed reposition pharyngoplasty (BRP) and upper airway stimulation (UAS) using electrical neurostimulation of the hypoglossal nerve.
Treatment allocation will occur after a satisfactory recovery in patients undergoing BRP and after titration of the device settings in patients treated with UAS. Treatment outcome will be assessed approximately 10 weeks thereafter by in-laboratory polysomnography. Two on-site follow-up visits will be scheduled to assess adherence and adverse events. The maximum treatment duration per participant will amount to 16 weeks.
Besides the aforementioned core clinical part, the study protocol will also include an optional exploratory part prior to surgery, assessing the physiological OSA traits and airflow features by means of polysomnography and drug-induced sleep endoscopy research measurements.
2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.
This study's enrollment of 26 is below the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →University Hospital, Antwerp is the lead sponsor of 242 studies on the registry; 69 are open to participants now.
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Exclusion Criteria:
Contra-indications related to acetazolamide treatment
Acetazolamide will be prescribed in unembellished white capsules of 250 mg. The drug will be administered twice daily in the morning and evening (approximately one hour before bedtime). The total treatment length will amount to 16 weeks. In case of side effects hampering treatment adherence, the daily dosage will be reduced to a single evening dose of 250 mg.
Drug: Acetazolamide
The placebo regimen will be identical.
Drug: Placebo
Oral acetazolamide tablets of 250 mg taken twice daily.
Also known as: Diamox, ATC code: S01EC01
Matching placebo tablets taken twice daily.
Apnea-hypopnea index (AHI)
Change in AHI (events/h) from baseline to follow-up. The AHI is an index of sleep apnea severity that encompasses the frequency of apneas (cessations in breathing) and hypopneas (reductions in airflow).
Time frame: 10 weeks of add-on therapy
Oxygen desaturation index (ODI)
Change in ODI (events/h) from baseline to follow-up. The ODI represents the average number of desaturation episodes (≥3%) per hour sleep.
Time frame: 10 weeks of add-on therapy
Oxygen saturation (SaO2)
Change in mean and minimal SaO2 (%) from baseline to follow-up.
Time frame: 10 weeks of add-on therapy
Changes in daytime sleepiness measured with the Epworth Sleepiness Scale (ESS)
The questionnaire asks subjects to rate their probability of falling asleep on a scale from 0 to 3 for eight different situations that most people encounter in their daily lives. The scores for the eight questions are added together to obtain a single number (0-24). An ESS score higher than 10 indicates the presence of excessive daytime sleepiness.
Time frame: 16 weeks of add-on therapy
Changes in sleep-related quality of life measured with the Functional Outcome of Sleep Questionnaire (FOSQ-10)
This questionnaire is an abbreviated version of the original 30-item version. The FOSQ-10 consists of 10 items that are distributed among 5 subscales: general productivity (2 items), activity level (3 items), vigilance (3 items), social outcomes (1 item), and intimacy and sexual relationships (1 item). The questionnaire has a 4-point scale. The total score is calculated as the sum of the subscale means and can range from 5 to 20. The minimal important difference ranges from 1.7 to 2.0 points.
Time frame: 16 weeks of add-on therapy
Changes in snoring intensity measured with a Visual Analogue Scale (VAS)
If patients have a bed partner, a standard 10-point VAS ranging from 0 (no snoring) to 10 (extreme snoring causing the bed partner to leave the bedroom or sleep separately) will be used to evaluate the subjective status of snoring during sleep. Heavy snoring corresponds to a snoring index of at least 7. A decrease of 3 points after treatment is considered significant. A satisfactory improvements is defined as a reduction to an index that is no longer experiences as bothersome (i.e. \<3).
Time frame: 16 weeks of add-on therapy
Incidence of adverse events
Safety and tolerability of study treatment.
Time frame: 16 weeks of add-on therapy
This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Acetazolamide
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