A Novel Pharmacological Therapy for Obstructive Sleep Apnea
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|ClinicalTrials.gov Identifier: NCT03919955|
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : September 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea||Drug: Atomoxetine Drug: Oxybutynin Drug: Placebo||Phase 1 Phase 2|
Aim 1 - Effect of AtoOxy on sleep apnea severity. In a randomized controlled double-blind crossover study, 48 patients with moderate-to-severe OSA will take atomoxetine-plus-oxybutynin ("AtoOxy") versus placebo nightly for 1 month, with a 2-week washout in between. The investigators will test the hypothesis that AtoOxy reduces the Apnea-hypopnea index (primary outcome measure), and improves the following secondary outcomes:
- Nocturnal oxygenation, per "hypoxic burden of sleep apnea"
- Frequency of arousals from sleep (Arousal index)
- Self-reported sleepiness (Epworth Sleepiness Scale)
- Disease-specific quality of life (Functional Outcomes of Sleep Questionnaire, Short Form).
- Disease-specific quality of life (Sleep Apnea Quality of Life Index, Short Form)
Additional pre-specified exploratory outcome measures will be assessed, including Visual Analog Scales (Sleep Quality, Treatment Satisfaction) and additional polysomnographic measures of sleep (Stage 1 sleep, %total sleep time). Adherence and adverse events will also be carefully monitored to assess repeated-dose tolerance of the intervention.
Aim 2 - Determine which patient phenotypes respond best to AtoOxy. Patients will also take part in an additional night before initiating study medication to measure the key mechanisms causing OSA. The investigators will prospectively test the hypothesis that greater pharyngeal collapsibility determines a reduced response to therapy. They will also separately test the hypotheses that a reduced muscle responsiveness, reduced baseline muscle activation, a higher arousal threshold, and a lower loop gain will facilitate a greater response to therapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Novel Pharmacological Therapy for Obstructive Sleep Apnea|
|Actual Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||May 2022|
Experimental: Atomoxetine and Oxybutynin
Participants will take Atomoxetine and Oxybutynin nightly for one month. Half doses will be given on the first three nights.
Atomoxetine 80 mg, per mouth, before bed
Other Name: Strattera
Oxybutynin 5 mg, per mouth, before bed
Other Name: Ditropan
Placebo Comparator: Placebo
Participants will take Placebos nightly for one month. Half doses will be given on the first three nights.
Placebo, per mouth, before bed
- Apnea-hypopnea index [AHI] [ Time Frame: one month ]Apneas and hypopneas per hour (3% desat and/or arousal), % change from baseline
- Hypoxic Burden [ Time Frame: one month ]Desaturation area under curve × event frequency
- Arousal index [ Time Frame: one month ]Scored EEG arousals per hour (>3 s), % change from baseline
- Epworth Sleepiness Scale [ Time Frame: one month ]Self-reported sleepiness on scale of 0-24, higher being more sleepy
- Functional Outcomes of Sleep Questionnaire, Short Form [ Time Frame: one month ]Disease-specific quality of life
- Sleep Apnea Quality of Life Index, Short Form [ Time Frame: one month ]Disease-specific quality of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919955
|Contact: Scott A Sands, PhDfirstname.lastname@example.org|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Lauren Hess 617-732-8976 email@example.com|
|Principal Investigator:||Scott A Sands, PhD||Brigham and Women's Hospital|