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Acetazolamide as a Means to Mitigate Falling Ventilatory Drive and Drive-dependent OSA

ConditionOSA
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age21-80
SponsorBrigham and Women's Hospital

About this trial

Obstructive sleep apnea (OSA) is a highly prevalent disorder that has major consequences for cardiovascular health, neurocognitive function, risk of traffic accidents, daytime sleepiness, and quality of life. For years, a "classic" model of OSA has been used to describe the disorder, which fails to capture it's complexity. Recently, a model for OSA called drive-dependent OSA was discovered be more prevalent in the OSA population. This drive-dependent OSA is due to ventilation instability that occurs during respiratory events however these individuals have spontaneous increases in drive during respiratory events that stabilize their airway (i.e., via improving upper airway muscle activity) and reduce the risk of respiratory events in people with OSA. Therefore, by stabilizing the ventilatory drive, OSA should be treatable. Acetazolamide is a pharmacological ventilatory stimulant and has been previously shown to reduce OSA severity. As such in this study, the goal is to demonstrate acetazolamide improves OSA severity in 'drive-dependent' OSA people by improving drive-related pharyngeal obstructions compared to the 'classic' OSA people.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ages 21-80 years

Suspected OSA (snoring, sleepiness, witnessed apneas, other clinical symptoms) or diagnosed OSA (severity not required)

Untreated; No use of OSA treatments within 2 weeks of the baseline study. No plans to start OSA treatments for the duration of the study protocol

Disqualifiers

Any unstable medical condition

Current use of the study medication.

Use of ventilatory stimulant or depressant medications that may complicated interpretation of results (including opioids, barbiturates, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).

Allergies to sulfonamides - e.g. acetazolamide, hydrochlorothiazide, furosemide, sulfasalazine, celecoxib, sumatriptan, and zonisamide.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Acetazolamide

    Drug

    Administered for 3 nights, half-dose (1 pill) on the first night followed by full dose (2x250mg pills) for 2 nights

  • Placebo

    Drug

    Placebo sugar pills administered for 3 nights, half-dose (1 pill) on the first night followed by full dose (2 pills) for 2 nights

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: AcetazolamideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage reduction of apnea-hypopnea Index (AHI) with active versus placebo therapy in drive-dependent vs classic OSA groups

The primary efficacy outcome measure is the apnea hypopnea index (3% desaturation or arousal), presented as a percent reduction from baseline. Differences in this measure with active versus placebo therapy will be assessed. The primary comparison will be the difference in this measure in drive-dependent versus classic OSA subgroups.

Time frame
1 night

Secondary outcomes

1

Hypoxic burden, %.min/hr

the respiratory event-associated area under the desaturation curve from pre-event baseline

Time frame
1 night
2

Arousal index, events/hr

average number of arousals per hour of total sleep time

Time frame
1 night
3

N1 sleep, %total sleep time

Percentage of stage 1 sleep as a proportion of total sleep time

Time frame
1 night

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Source ClinicalTrials.gov
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