Health TrialsbyHealthPanel

Endotypic Traits and Obstructive Sleep Apnea Surgery

ConditionObstructive Sleep Apnea
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of California, Los Angeles

About this trial

This study will examine factors associated with outcomes after soft palate surgery and medications (acetazolamide, eszopiclone) that may treat other potential causes of obstructive sleep apnea (loop gain, arousal threshold).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age ≥21 years;

moderate to severe OSA (obstructive AHI ≥ 15 events/hour);

central/mixed apnea index <5 events/hour;

intolerance of positive airway pressure (defined as use < 2 hours/night at least 5 nights/week);

Disqualifiers

history of allergic reaction to either of the study drugs;

subjects with prior serious allergic reaction (such as Stevens-Johnson syndrome) to sulfonamides;

subjects with a history of hypersensitivity to either of the two study drugs;

subjects who are on high-dose aspirin therapy due to risk of severe metabolic acidosis;

Trial design

Design model

Crossover

Treatments tested in this trial

  • Acetazolamide 500 MG QHS

    Drug

    Acetazolamide

  • Eszopiclone 3 mg QHS

    Drug

    Eszopiclone

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: AcetazolamideExperimental treatment 1 intervention
Group B: Acetazolamide/EszopicloneExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Apnea-hypopnea index

apneas plus hypopneas per hour of sleep

Time frame
6 months

Secondary outcomes

Other outcomes

1

Pclose

upper airway closing pressure, as measured with administration of positive airway pressure therapy and observation of airway dimensions with flexible fiberoptic endoscopy

Time frame
6 months
2

Vpassive

ventilation at normal ventilatory drive, as measured using software to analyze raw polysomnogram data

Time frame
6 months
3

Loop gain

ventilatory drive response to a 1 cycle/min reduction in ventilation (ventilatory control), as measured using software to analyze raw polysomnogram data

Time frame
6 months
4

Arousal threshold

median ventilatory drive immediately preceding scored EEG arousals (propensity to wake up), as measured using software to analyze raw polysomnogram data

Time frame
6 months

Sponsors and contacts

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

University of California, Los Angeles

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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