Drug therapy to treat sleep apnoea trial

Phase 2

Completed

• Conditions: Obstructive sleep apnoea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12620000662965
• Lead Sponsor: Flinders University

Brief Summary

A single 4mg dose of reboxetine modestly reduces obstructive sleep apnea (OSA) severity without further improvement with the addition of an antimuscarinic. These findings provide insight into the role of norepinephrine reuptake inhibitors on upper airway stability during sleep and are important for pharmacotherapy development for OSA.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-09
• Study Completion: 2020-12-03
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Otherwise healthy men and women with obstructive sleep apnoea aged 18-65 years
BMI between 18.5 and 40.0 kg/m2, inclusive, at visit 1.

Exclusion Criteria

-Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
Medical Conditions
1.History of narcolepsy.
2.Clinically significant craniofacial malformation.
3.Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or poorly controlled hypertension.
4.Clinically significant neurological disorder, including epilepsy/convulsions.
5.History of schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-V (DSM V) or International Classification of Disease tenth edition criteria.
6.History of attempted suicide or suicidal ideation within 1 year prior to screening, or current suicidal ideation.
7.History of clinically significant constipation, gastric retention, or urinary retention, benign prostatic hyperplasia.
8.History of moderate or severe hepatic or renal impairment.
9.History of drug abuse or substance use disorder as defined in DSM-V within 12 months.
10.A significant acute illness or infection requiring medical treatment in the past 30 days.
11.Clinically significant cognitive dysfunction.
12.Narrow angle glaucoma.
13.Women who are pregnant or nursing.
14.Allergy to the study medications
15.Any medication known to influence breathing, sleep/arousal or muscle physiology.
16.Claustrophobia.
17.Use of medications from the list of disallowed concomitant medications.
18.Treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors, strong cytochrome P450 2D6 (CYP2D6) inhibitors, or monoamine oxidase inhibitors (MAOI) within 14 days of the start of study.
Prior/Concurrent Clinical Study Experience
19.Use of another investigational agent within 30 days or 5 half-lives, whichever is longer, prior to dosing.
Other Exclusions
20.<5 hours typical sleep duration.
21.Night- or shift-work sleep schedule.
22.Employment as a commercial driver or operator of heavy or hazardous equipment.
23.Smoking more than 10 cigarettes or 2 cigars per day.
24.Unwilling to use contraception during the study (if relevant).
25.Unwilling to avoid alcohol on the days of the study.
26.Unwilling to limit caffeinated beverage intake (e.g., coffee, cola, tea) to 400 mg/day or less of caffeine, not to be used within 3 hours of bedtime on study days.
27.Any condition that in the investigator’s opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation.
28.Participant considered by the investigator, for any reason, an unsuitable candidate to receive the study medications or unable or unlikely to understand or comply with the study design.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep apnoea severity using the apnoea/hypopnoea index from the overnight polysomnogram[Single acute overnight sleep studies (placebo vs. drug nights, approximately 1 week wash out between studies)]

Secondary Outcome Measures

Name	Time	Method
Sleep efficiency from the overnight polysomnogram[Single acute overnight sleep studies (placebo vs. drug nights, approximately 1 week wash out between studies)];Karolinska Sleepiness Scale (KSS) questionnaire measured after awakening after each sleep study[After each overnight sleep study (placebo vs. drug nights, approximately 1 week wash out between studies)];Hypoxemia from the overnight polysomnogram measured using pulse oximetry[Single acute overnight sleep studies (placebo vs. drug nights, approximately 1 week wash out between studies)];Alertness measured after awakening after each sleep study using the AusEd driving simulator[After each overnight sleep study (placebo vs. drug nights, approximately 1 week wash out between studies)];arousal index (number of events/h sleep) measured via polysomnography during each overnight sleep study[Single acute overnight sleep studies (placebo vs. drug nights, approximately 1 week wash out between studies)]