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| Name | Class |
|---|---|
| Apnimed | INDUSTRY |
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This study evaluates the combination of two drugs (AD128), to treat obstructive sleep apnea (OSA) severity. After a baseline evaluation and during 7 days, half of the participants will randomly receive this drug combination (AD128) and the other will receive a placebo, i.e. a drug without pharmaceutical effect. Neither the participants, nor the investigators will know in which arm participants are until the end of the study. After one week of trial, an evaluation will be perform and will be follow by one week without any treatment. During the third and last week of trial, there will be a crossover of the groups, i.e. the participants of the first group who took the two drugs (AD128) during the first week will take a placebo and those who took the placebo will take the drugs combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AD128 | Experimental | The study specific intervention includes per oral administration of two capsules of AD128, once daily, just before lights out, for 7 days. |
|
| placebo | Placebo Comparator | Two placebo capsules (Mannitol) will be administered for the control intervention once daily, just before light outs, for one week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD128 | Drug | Oral administration of two capsules before sleep for 7 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-hypopnea index (AHI) | Change from baseline AHI (events/h) measured via polysomnography between the week of investigational treatment (AD128) and the week of placebo treatment. | Day 7 and 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen desaturation index (ODI) | Change from baseline ODI (events/h) measured via polysomnography between the week of investigational treatment (AD128) and the week of placebo treatment. | Day 7 and 21 |
| Oxygen desaturation index (ODI) in REM and NREM |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raphael Heinzer, MD | University Hospital of Lausanne (CHUV) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois | Lausanne | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36861433 | Derived | Berger M, Solelhac G, Marchi NA, Dussez R, Bradley B, Lecciso G, Heiniger G, Bayon V, Van Den Broecke S, Haba-Rubio J, Siclari F, Heinzer R. Effect of oxybutynin and reboxetine on obstructive sleep apnea: a randomized, placebo-controlled, double-blind, crossover trial. Sleep. 2023 Jul 11;46(7):zsad051. doi: 10.1093/sleep/zsad051. |
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Individual participant data (IPD) could be transmitted on request after publication to researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D000077260 | Sleepiness |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D008353 | Mannitol |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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This is a randomized, placebo-controlled, double-blind crossover study
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Evaluators, investigators and patients will be blinded to treatment allocation. Treatments will be prepared and conditioned by the Pharmacy Service of the University Hospital of Lausanne according to a randomisation list performed by an independent statistician. The Pharmacy service is completely independent from the Center for Investigation and Research in Sleep (CIRS). Unblinding will be performed after statistical analysis is completed by a statistician blinded to treatment assignment.
| Mannitol |
| Drug |
Oral administration of two capsules before sleep for 7 days. |
|
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Change from baseline ODI (events/h) measured via polysomnography during rapid eye movement (REM) and non rapid eye movement (NREM) sleep between the week of investigational treatment (AD128) and the week of placebo treatment.
| Day 7 and 21 |
| Hypoxic load | Change from baseline hypoxic load (area under the curve of 3% oxygen desaturation related to apnea-hypopnea events) measured via polysomnography between the week of investigational treatment (AD128) and the week of placebo treatment. | Day 7 and 21 |
| Hypoxic load in REM and NREM | Change from baseline hypoxic load (area under the curve of 3% oxygen desaturation related to apnea-hypopnea events) measured via polysomnography during rapid eye movement (REM) and non rapid eye movement (NREM) sleep between the week of investigational treatment (AD128) and the week of placebo treatment. | Day 7 and 21 |
| Arousal index | Change from baseline arousal index (events/h) measured via polysomnography between the week of investigational treatment (AD128) and the week of placebo treatment. | Day 7 and 21 |
| Arousal index in REM and NREM | Change from baseline arousal index (events/h) measured via polysomnography during rapid eye movement (REM) and non rapid eye movement (NREM) sleep between the week of investigational treatment (AD128) and the week of placebo treatment. | Day 7 and 21 |
| Pulse wave amplitude (PWA) drops | Change from baseline PWA drops (events/h) measured via polysomnography between the week of investigational treatment (AD128) and the week of placebo treatment. | Day 7 and 21 |
| Pulse wave amplitude (PWA) drops in REM and NREM | Change from baseline PWA drops (events/h) measured via polysomnography during rapid eye movement (REM) and non rapid eye movement (NREM) sleep between the week of investigational treatment (AD128) and the week of placebo treatment. | Day 7 and 21 |
| Apnea-hypopnea index (AHI) in REM and NREM | Change from baseline AHI (events/h) measured via polysomnography during rapid eye movement (REM) and non rapid eye movement (NREM) sleep between the week of investigational treatment (AD128) and the week of placebo treatment. | Day 7 and 21 |
| Percentage of REM sleep | Change from baseline REM sleep (% of total sleep time) measured via polysomnography between the week of investigational treatment (AD128) and the week of placebo treatment. | Day 7 and 21 |
| Percentage of N1 | Change from baseline sleep stage 1 (N1: % of total sleep time) measured via polysomnography between the week of investigational treatment (AD128) and the week of placebo treatment. | Day 7 and 21 |
| Percentage of N2 | Change from baseline sleep stage 2 (N2: % of total sleep time) measured via polysomnography between the week of investigational treatment (AD128) and the week of placebo treatment. | Day 7 and 21 |
| Percentage of N3 | Change from baseline sleep stage 3 (N3: % of total sleep time) measured via polysomnography between the week of investigational treatment (AD128) and the week of placebo treatment. | Day 7 and 21 |
| Percentage of alpha wave | Change from baseline alpha wave frequency (8-13 Hz - % of total sleep time) measured via polysomnography in REM and NREM between the week of investigational treatment (AD128) and the week of placebo treatment. | Day 7 and 21 |
| Percentage of beta wave | Change from baseline beta wave frequency (13-30 Hz - % of total sleep time) measured via polysomnography in REM and NREM between the week of investigational treatment (AD-128) and the week of placebo treatment. | Day 7 and 21 |
| Percentage of gamma wave | Change from baseline gamma wave frequency (30-100 Hz - % of total sleep time) measured via polysomnography in REM and NREM between the week of investigational treatment (AD128) and the week of placebo treatment. | Day 7 and 21 |
| Percentage of theta wave | Change from baseline theta wave frequency (4-8 Hz - % of total sleep time) measured via polysomnography in REM and NREM between the week of investigational treatment (AD128) and the week of placebo treatment. | Day 7 and 21 |
| Percentage of delta wave | Change from baseline delta wave frequency (1-4 Hz - % of total sleep time) measured via polysomnography in REM and NREM between the week of investigational treatment (AD128) and the week of placebo treatment. | Day 7 and 21 |
| Reaction time PVT | Change from baseline reaction time (in ms) during Psychomotor Vigilance Task (PVT). During 10 min, subjects were instructed to press a button as quickly as possible when a red millisecond-counter appeared on a small screen (PVT-192, Ambulatory Monitoring Inc.). | Day 7 and 21 |
| Lapse PVT | Change from baseline lapse time (in ms) during Psychomotor Vigilance Task (PVT) and defined as reaction time > 500 ms). During 10 min, subjects were instructed to press a button as quickly as possible when a red millisecond-counter appeared on a small screen (PVT-192, Ambulatory Monitoring Inc.). | Day 7 and 21 |
| Chronic Excessive daytime sleepiness (EDS) | Change from baseline Epworth Sleepiness Scale (ESS) score between the week of investigational treatment (AD128) and the week of placebo treatment. The ESS is a 8-item questionnaire. ESS score can range from 0 to 24. The higher the ESS score, the higher daytime sleepiness. | Day 7 and 21 |
| Acute Excessive daytime sleepiness (EDS) | Change from baseline Stanford Sleepiness Scale (SSS) score between the week of investigational treatment (AD128) and the week of placebo treatment. Consisting of only one item, the scale requires respondents to select one of seven statements best representing their level of perceived sleepiness. The scale range from 1 to 7. Higher score indicates greater sleepiness. | Day 7 and 21 |
| Sleep quality | Change from baseline visual analogic scale (VAS) sleep quality score between the week of investigational treatment (AD128) and the week of placebo treatment. Score ranges from 0 to 10. Higher score indicates better sleep quality. | Day 7 and 21 |
| Fatigue | Change from baseline Pichot scale score between the week of investigational treatment (AD128) and the week of placebo treatment. The Pichot scale is a 8-items auto-questionnaire to assess excessive fatigue. Score varies between 0 and 32, a score > 22 indicates excessive fatigue. | Day 7 and 21 |
| Systolic and diastolic blood pressure | Change from baseline office systolic and diastolic blood pressure (BP in mm Hg) between the week of investigational treatment (AD128) and the week of placebo treatment. The Pichot scale is a 8-items auto-questionnaire to assess excessive fatigue. Score varies between 0 and 32, a score > 22 indicates excessive fatigue. | Day 7 and 21 |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |