Obstructive sleep apnea MedDRA version: 25.0 Level: LLT Classification code 10055577 Term: Obstructive sleep apnea syndrome System Organ Class: 100000004855
Conditions
Interventions
Trade Name: EDRONAX
Pharmaceutical Form: Tablet
INN or Proposed INN: Reboxetine
Other descriptive name: Reboxetine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4
Sponsors
CHU Brugmann
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients between 18 and 70 years suffering from moderate OSA (AHI 15 – 30/hour) diagnosed by a full in-hospital polysomnography (PSG). - Inclusion of patients should occur after a negative highly sensitive pregnancy test. Women of child bearing age (WOCBP) should use a highly effective method of contraception preferably with low user dependency*. Contraception should be maintained during treatment and until the end of relevant systemic exposure (day 30). Male healthy volunteers with a WOCBP partner should use a condom during treatment and until the end of relevant systemic exposure in WOCBP. *Birth control methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include: - combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation 1: o oral o intravaginal o transdermal - progestogen-only hormonal contraception associated with inhibition of ovulation: o oral o injectable o implantable - intrauterine device (IUD) - intrauterine hormone-releasing system ( IUS) - bilateral tubal occlusion - vasectomised partner (provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomised partner has received medical assessment of the surgical success). - sexual abstinence (only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments: 30 days. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Non-stabilized cardiovascular disorders - Medical history of urinary retention, intestinal occlusion, glaucoma, epilepsy, neurodegenerative disorders, unipolar and bipolar mood disorders. - Ongoing pharmacological treatments: antidepressants, antiepileptic drugs, antiparkinsonian drugs. - Ongoing treatment for Obstructive sleep apnea - Diagnosis of central sleep apnea (CSA) at baseline polysomnography - Pregnancy - Professional drivers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 50% reduction in apnea/hypopnea index (AHI) after 1 month of treatment compared to baseline.;Secondary Objective: Significant improvements on different psychometric measurements (PSQI, ESS, FSS, FOSQ) as well as on other polysomnographic respiratory parameters (snoring, oxygen desaturation index – ODI, time spent below 90% oxygen saturation). Furthermore, we expect a good tolerance profile with a low number of drop-outs due to side effects. Finally, polysomnographic parameters related to sleep structure and quality (total sleep time – TST, sleep onset latency – SOL, wake time after sleep onset – WASO, sleep efficiency – SE, proportions of light sleep – N1/N2, deep sleep – N3, REM sleep, micro arousal index – MAI, intrusions of alpha waves in delta sleep) will be monitored.;Primary end point(s): 50% reduction in apnea/hypopnea index (AHI) after 1 month of treatment compared to baseline.;Timepoint(s) of evaluation of this end point: after 1 month of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Significant improvements on different psychometric measurements (PSQI, ESS, FSS, FOSQ) as well as on other polysomnographic respiratory parameters (snoring, oxygen desaturation index – ODI, time spent below 90% oxygen saturation). Furthermore, we expect a good tolerance profile with a low number of drop-outs due to side effects. Finally, polysomnographic parameters related to sleep structure and quality (total sleep time – TST, sleep onset latency – SOL, wake time after sleep onset – WASO, sleep efficiency – SE, proportions of light sleep – N1/N2, deep sleep – N3, REM sleep, micro arousal index – MAI, intrusions of alpha waves in delta sleep) will be monitored.;Timepoint(s) of evaluation of this end point: after 1 month of treatment | — |
Countries
Belgium
Contacts
Public ContactSleep Laboratory (U78)
CHU Brugmann
Outcome results
None listed