The Role of the LC-NA System in Sleep RegulationPhase 1DMTN_FragSleepNCT07167316
The Role of the LC-NA System in Experimental Sleep Fragmentation
A Phase 1 study testing DMTN, Auditory Stimulation and Placbo in people with The Role of the LC-NA System in Sleep Regulation, run by Hans-Peter Landolt at 1 site in Switzerland.
Trial summary
Sleep-wake regulation affects every person's life, yet the molecular mechanisms underlying these processes remain poorly understood. In particular, the microstructure of sleep has not been sufficiently studied to explain how sleep produces a feeling of restoration the following morning. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- The Role of the LC-NA System in Sleep Regulation
- What is being tested?
- DMTN, Auditory Stimulation and Placbo
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 May 2026to 1 Oct 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 - 35 years (inclusive)
- Body-Mass-Index (BMI): 18.5 < BMI < 25
- Non-nicotine user status
- Habitual consumption of 5 or fewer alcoholic beverages / week
- Habitual consumption of 3 or fewer caffeinated beverages / day
- Habitual average sleep duration 7-9 h / night
Show all 11Show fewer
- Normal or corrected-to-normal vision
- Insomnia severity Index (ISI) Score: ISI < 8
- Ability to understand and speak German language
- Normal hearing ability (applies only to Sleep Study Part)
- Ability and willingness to provide informed consent as documented by dated signature
Who cannot join
- Present use of medication that may interfere with sleep or study drugs
- Travel across 3 or more time zones within 3 months of study start
- Habitual napping
- Extreme chronotype, determined by reduced Morningness-Eveningness Questionnaire (rMEQ) score: 8 < rMEQ > 21)
- Shift working within 2 weeks prior to the screening visit
- History of or presence of a trauma- or stressor-related disorder
Show all 18Show fewer
- Serious acute or chronic neurological, mental, or general medical conditions that, in the opinion of the investigator, may pose a risk to participation or affect study measurements
- History of or presence of a sleep wake disorder
- Use of illicit drugs (positive urinary drug screening)
- Male participants who are not vasectomised for at least 6 months prior to dosing and who are sexually active with a female partner of childbearing potential not willing to use one of the following acceptable contraceptive methods from the first dose and for 3 months after the last dose:
- Use of condom and/or hormonal contraceptive (e.g., oral, patch, depot injection, implant, vaginal ring, intrauterine device) or non-hormonal intrauterine device used for at least 4 weeks prior to sexual intercourse for the female partner;
- Male participants (including men who have had a vasectomy) with a pregnant partner not willing to use a condom from the first dose and for 3 months after the last dose.
- Male participants not willing to abstain from sperm donation for 3 months after the last dose
- Females of childbearing potential who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomised at least 6 months prior to the first study drug administration) not willing to use one of the following acceptable contraceptive methods throughout the study and for at least 3 months after the last study drug administration:
- Simultaneous use of condom and hormonal contraceptive (e.g., oral, patch, depot injection, implant, vaginal ring, intrauterine device) or non-hormonal intrauterine device used for at least 4 weeks prior to sexual intercourse for the female partner;
- Females of non-childbearing potential who are neither: Post-menopausal (status defined as an absence of menses for at least 12 months prior to the first study drug administration); or Surgically sterilized (complete hysterectomy or bilateral oophorectomy at least 3 months prior to the first study drug administration)
- Faints at the sight of blood (applies only for the pharmacokinetic-part of the study)
- Has participated in a study < 30 days or a study such as this (i.e., experimental trauma) at all.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University of Zurich, Institute of Pharmacology and Toxicology
Zurich, 8057
Rafael Wespi, PhD., +41 44 635 59 61, rafael.wespi@pharma.uzh.ch
Patricia Sonderegger, MSc, +41 44 635 59 61, patricia.sonderegger@pharma.uzh.ch
About this study
Official title: Phase I, Randomized, Placebo-Controlled Study on the Role of the LC-NA System in Experimental Sleep Fragmentation With Buccal Dexmedetomidine.
Sleep-wake regulation affects every person's life, yet the molecular mechanisms underlying these processes remain poorly understood. In particular, the microstructure of sleep has not been sufficiently studied to explain how sleep produces a feeling of restoration the following morning. Stress also plays a significant role in sleep regulation. This study aims to investigate the role of norepinephrine in these processes.
Read the detailed description
Following a screening night and a baseline sleep recording, participants undergo three experimental nights in the sleep laboratory. On each of these nights, sleep is intentionally disrupted using auditory stimuli to induce fragmentation. To investigate potential counteracting effects on sleep quality, participants receive either a low dose (64 µg), a high dose (96 µg) of dexmedetomidine (DMTN)-a compound known to reduce norepinephrine levels-or a placebo. All participants experience each condition in a randomized, double-blind, crossover design, with the sequence of administration varying between individuals. Neither the participants nor the study team are aware of the assigned condition on any given night.
In a second part of the study, three additional nights are conducted to assess the pharmacokinetics and pharmacodynamics of dexmedetomidine. During these nights, participants again receive either the low dose (64 µg), high dose (96 µg), or placebo (in randomized order). Blood samples are collected at multiple time points to characterize the compound's pharmacokinetic profile, and additional physiological outcomes are measured to evaluate pharmacodynamic effects.
- Being tested
- DMTN, Auditory Stimulation, Placbo
- Keywords
- Cross-Over, placebo controlled, randomized, sleep disturbance, auditory stimulation, healthy, Stress, LC-NA, pharmacokinetics, pharmacodynamics
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMTNDrug
Dexmedetomidine is a highly selective alpha-2 adrenergic receptor agonist that reduces the release of norepinephrine by inhibiting activity in the locus coeruleus, a key brain region involved in arousal and stress responses. In this study, dexmedetomidine will be administered as an oro-dispersible tablet applied buccally, allowing for rapid absorption through the oral mucosa.
Auditory StimulationOther
Auditory tones will be presented throughout the night at individually calibrated intensities, adjusted to each participant's hearing threshold, in order to induce controlled sleep fragmentation without full awakenings.
PlacboDrug
Oro-dispersible placebo tablet identical in appearance and packaging to the active Dexmedetomidine tablet.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | Experimental: 64 µg Dexmedetomidine Receives: Drug: DMTN |
| High Dose | Experimental | Experimental: 96 µg Dexmedetomidine Receives: Drug: DMTN |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placbo |
| Low Dose + Auditory Stimulation | Experimental | Experimental: 64 µg Dexmedetomidine + Auditory Stimulation Receives: Drug: DMTN; Other: Auditory Stimulation |
| High Dose + Auditory Stimulation | Experimental | Experimental: 96 µg Dexmedetomidine + Auditory Stimulation Receives: Drug: DMTN; Other: Auditory Stimulation |
| Placebo + Auditory Stimulation | Placebo comparator | Placebo + Auditory Stimulation Receives: Other: Auditory Stimulation; Drug: Placbo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Sleep Time (TST)
The total amount of time spent in all sleep stages (N1, N2, N3, and REM) combined, measured in minutes.
Measured: Baseline Night, Experimental Night 1, Experimental Night 2, Experimental Night 3
Change in Wake After Sleep Onset (WASO)
The total time spent awake in minutes after sleep has been initiated and before the final awakening.
Measured: Baseline Night, Experimental Night 1, Experimental Night 2, Experimental Night 3
Change in Sleep Efficiency
The percentage of time spent asleep relative to the total time spent in bed (Total Sleep Time / Time in Bed * 100).
Measured: Baseline Night, Experimental Night 1, Experimental Night 2, Experimental Night 3
Change in Sleep Onset Latency (SOL)
The time in minutes from "lights out" to the first epoch of any sleep stage.
Measured: Baseline Night, Experimental Night 1, Experimental Night 2, Experimental Night 3
Percentage of Time in N1, N2, N3 and REM-Sleep
The proportion of Total Sleep Time spent in Stage N1, N2, N3 and REM-Sleep.
Measured: Baseline Night, Experimental Night 1, Experimental Night 2, Experimental Night 3
Change in Arousal Index
The number of EEG arousals per hour of sleep.
Measured: Baseline Night, Experimental Night 1, Experimental Night 2, Experimental Night 3
Maximum Plasma Concentration (Cmax) of Dexmedetomidine
The maximum observed concentration of dexmedetomidine in plasma following administration, determined from serial blood sampling.
Measured: Up to 24 hours post-dose on Experimental Night 1, Experimental Night 2, and Experimental Night 3
Time to Maximum Plasma Concentration (Tmax) of Dexmedetomidine
The time at which the maximum plasma concentration (Cmax) of dexmedetomidine is observed following administration.
Measured: Up to 24 hours post-dose on Experimental Night 1, Experimental Night 2, and Experimental Night 3
Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Point (AUC0-t) of Dexmedetomidine
The cumulative drug exposure over time, calculated as the area under the dexmedetomidine plasma concentration versus time curve from the time of dosing to the last quantifiable plasma concentration.
Measured: Up to 24 hours post-dose on Experimental Night 1, Experimental Night 2, and Experimental Night 3
Change in Plasma Noradrenaline Concentration
Assessment of the change in endogenous noradrenaline levels in plasma, measured from samples collected at predetermined timepoints following intervention.
Measured: Up to 24 hours post-dose on Experimental Night 1, Experimental Night 2, and Experimental Night 3
Secondary outcomes (16)
Dim Light Melatonin Onset (DLMO)
The clock time at which the concentration of salivary melatonin first exceeds a calculated threshold, determined by serial sampling in dim light conditions. DLMO is a key marker of circadian phase.
Measured: Evening after Experimental Night 1, Evening after Experimental Night 2, Evening after Experimental Night 3
Change in Autonomic Arousal Measured by Pupillometry
To quantify autonomic arousal, pupillometry will be performed at different schedules. During sleep-focused visits, assessments are at pre-dose, 15 minutes post-dose, and 15 minutes after lights on. During pharmacokinetic-focused visits, additional assessments are made at 2 and 4 hours post-dose. Autonomic arousal will be reported as a single index derived from pupil diameter and its fluctuations.
Measured: Pre-dose, 15 minutes post-dose, 2 hours post-dose (only PK-Part), 4 hours post-dose (only PK-Part), 15 minutes after lights on.
Change in Heart Rate Variable
Heart rate variables, will be continuously monitored to assess autonomic nervous system regulation.
Measured: Baseline Night, Experimental Night 1, Experimental Night 2, Experimental Night 3
Resting-state EEG spectral analysis
Wake-state EEG will be recorded before and after sleep to assess changes in power spectral density, especially in alpha and theta bands.
Measured: Pre-sleep (evening) and post-sleep (morning) at the baseline night and each of the 3 overnight experimental visits (together with the "Change in Autonomic Arousal Measured by Pupillometry" acquisition).
Nocturnal thermoregulation
Body temperature will be continuously monitored to evaluate effects of Dexmedetomidine on thermoregulation.
Measured: Baseline Night, Experimental Night 1, Experimental Night 2, Experimental Night 3
Pre-sleep arousal levels (PSAS)
The Pre-Sleep Arousal Scale (PSAS, score range 16 - 80, with higher scores indicating higher levels of arousal) will be administered to assess cognitive and somatic arousal prior to bedtime.
Measured: Morning of Baseline Night, Morning of Experimental Night 1, Morning of Experimental Night 2, Morning of Experimental Night 3
Sedation depth (OAAS scale)
Observer-rated sedation will be assessed using the Observer's Assessment of Alertness/Sedation Scale (score 1 - 5).
Measured: Completed at each of the 3 overnight experimental visits similar to the blood sampling timepoints in the sleep opportunity window.
Mood states (POMS-16 and A-SIQ)
Mood and sleep inertia will be evaluated using the 16-item Profile of Mood States (POMS-16, 16 items from 0-4; assesses mood across five subscales, with higher scores indicating greater intensity except for vigor) and the Acute Sleep Inertia Questionnaire (A-SIQ, 22 items from -3 - +3, with higher scores indicate more sleep inertia and 1 item with visual analoge scale) upon awakening.
Measured: Morning following Baseline Night, Morning following Experimental Night 1, Morning following Experimental Night 2, Morning following Experimental Night 3
State-Trait Anxiety Inventory (STAI)
Trait and state anxiety will be assessed via the STAI-Y1 (STAI-Y1, 20 items from 1-4; higher scores reflect greater momentary anxiety) questionnaire to explore mood modulation effects of the experimental sleep fragmentation and Dexmedetomidine.
Measured: Morning following Baseline Night, Morning following Experimental Night 1, Morning following Experimental Night 2, Morning following Experimental Night 3
Psychomotor vigilance (PVT)
Vigilance performance will be assessed using the Psychomotor Vigilance Task (PVT) upon awakening.
Measured: Morning following Baseline Night, Morning following Experimental Night 1, Morning following Experimental Night 2, Morning following Experimental Night 3
Number of Participants with Orthostatic Intolerance as Defined by Schellong Test Criteria
The number of participants who are unable to complete the full duration of the Schellong test or exhibit clear signs of intolerance. This is defined as the occurrence of any of the following: participant-reported dizziness or pre-syncope requiring termination of the test; investigator-observed excessive swaying or stumbling requiring intervention; or early termination of the test at the participant's request.
Measured: Morning following Baseline Night, Morning following Experimental Night 1, Morning following Experimental Night 2, Morning following Experimental Night 3
Number of Participants Exhibiting Clinically Significant Gait Instability During a Standardized Gait Task
Postural stability and adaptation during walking will be assessed via a standardized gait task. Clinically significant instability is defined as the occurrence of any of the following during the task: any stumble, trip, or loss of balance; requiring physical assistance or support from an external surface (e.g., a wall); or an inability to complete the prescribed walking task as instructed.
Measured: In the morning after 8 hours sleep opportunity window of the baseline night and each of the 3 overnight experimental visits. For the PK part additional timepoints (2 & 4 hours post dosing) will be measured during sleep opportunity window of 8 hours.
Change in Power of EEG Infra-Slow Oscillations (<0.1 Hz) During NREM Sleep
The power spectral density of EEG activity (measured in μV²/Hz) in the infra-slow frequency band (<0.1 Hz), calculated from overnight polysomnography (PSG) recordings during NREM sleep. The change from the placebo condition to the DMTN condition will be calculated to assess the drug's effect on rhythmic noradrenergic signalling.
Measured: Baseline Night, Experimental Night 1, Experimental Night 2, Experimental Night 3
Change in Blood Oxygen Saturation (SpO2)
Peripheral blood oxygen saturation (SpO2), measured as a percentage, will be continuously monitored via pulse oximetry during the pharmacokinetic (PK) study visits.
Measured: Continuously during each 3 of the the pharmacokinetic overnight experimental visits.
Change in Systolic Blood Pressure
Systolic blood pressure (SBP), measured in mmHg, will be assessed at discrete time points in the evening and morning to evaluate autonomic changes.
Measured: Evening and Morning of Baseline Night, Evening and Morning of Experimental Night 1, Evening and Morning of Experimental Night 2, Evening and Morning of Experimental Night 3
Change in Diastolic Blood Pressure
Diastolic blood pressure (DBP), measured in mmHg, will be assessed at discrete time points in the evening and morning to evaluate autonomic changes.
Measured: Evening and Morning of Baseline Night, Evening and Morning of Experimental Night 1, Evening and Morning of Experimental Night 2, Evening and Morning of Experimental Night 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start21 May 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Role of the LC-NA System in Sleep RegulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will first spend a screening night to adapt to the sleep laboratory environment, followed by a baseline night without any interventions. Subsequently, they will complete three experimental nights, during which sleep will be disrupted using auditory stimulation. On each of these nights, participants will receive either a high dose, a low dose of dexmedetomidine, or a placebo. The order in which these three conditions are administered will be randomized across participants. In a second part of the study, participants will spend three nights again receiving the high dose, low dose, or placebo in randomized order. During these nights, blood samples will be collected for pharmacokinetic analyses, and additional physiological measures will be recorded to assess pharmacodynamic effects.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hans-Peter Landolt
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust
- Responsible party
- Sponsor-investigator, Hans-Peter Landolt, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167316
- Sponsor's protocol ID
- 2025-01005
- Other IDs
- 2025
- Acronym
- DMTN_FragSleep
- Status last verified
- Sep 2025
- First submitted
- 17 Jul 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Any disclosure of information to individuals not directly involved in the study must be approved by the owner of the data.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Randomized, Placebo-Controlled Study on the Role of the LC-NA System in Experimental Sleep Fragmentation With Buccal Dexmedetomidine.
- ClinicalTrials.gov ID
- NCT07167316
- Acronym / sponsor ID
- DMTN_FragSleep / 2025-01005
- Keywords
- Cross-Over, placebo controlled, randomized, sleep disturbance, auditory stimulation, healthy, Stress, LC-NA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Hans-Peter LandoltUniversity, hospital or other
- Collaborators
- Wellcome Trust
- Study start
- 21 May 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sleep-wake regulation affects every person's life, yet the molecular mechanisms underlying these processes remain poorly understood. In particular, the microstructure of sleep has not been sufficiently studied to explain how sleep produces a feeling of restoration the following morning. Stress also plays a significant role in sleep regulation. This study aims to investigate the role of norepinephrine in these processes.
Detailed description
Following a screening night and a baseline sleep recording, participants undergo three experimental nights in the sleep laboratory. On each of these nights, sleep is intentionally disrupted using auditory stimuli to induce fragmentation. To investigate potential counteracting effects on sleep quality, participants receive either a low dose (64 µg), a high dose (96 µg) of dexmedetomidine (DMTN)-a compound known to reduce norepinephrine levels-or a placebo. All participants experience each condition in a randomized, double-blind, crossover design, with the sequence of administration varying between individuals. Neither the participants nor the study team are aware of the assigned condition on any given night.
In a second part of the study, three additional nights are conducted to assess the pharmacokinetics and pharmacodynamics of dexmedetomidine. During these nights, participants again receive either the low dose (64 µg), high dose (96 µg), or placebo (in randomized order). Blood samples are collected at multiple time points to characterize the compound's pharmacokinetic profile, and additional physiological outcomes are measured to evaluate pharmacodynamic effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- Each participant will first spend a screening night to adapt to the sleep laboratory environment, followed by a baseline night without any interventions. Subsequently, they will complete three experimental nights, during which sleep will be disrupted using auditory stimulation. On each of these nights, participants will receive either a high dose, a low dose of dexmedetomidine, or a placebo. The order in which these three conditions are administered will be randomized across participants. In a second part of the study, participants will spend three nights again receiving the high dose, low dose, or placebo in randomized order. During these nights, blood samples will be collected for pharmacokinetic analyses, and additional physiological measures will be recorded to assess pharmacodynamic effects.
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Drug: DMTNExperimental: 64 µg Dexmedetomidine |
| High Dose | Experimental | Drug: DMTNExperimental: 96 µg Dexmedetomidine |
| Placebo | Placebo comparator | Drug: PlacboPlacebo |
| Low Dose + Auditory Stimulation | Experimental | Drug: DMTN, Other: Auditory StimulationExperimental: 64 µg Dexmedetomidine + Auditory Stimulation |
| High Dose + Auditory Stimulation | Experimental | Drug: DMTN, Other: Auditory StimulationExperimental: 96 µg Dexmedetomidine + Auditory Stimulation |
| Placebo + Auditory Stimulation | Placebo comparator | Other: Auditory Stimulation, Drug: PlacboPlacebo + Auditory Stimulation |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Age between 18 - 35 years (inclusive)
- Body-Mass-Index (BMI): 18.5 < BMI < 25
- Non-nicotine user status
- Habitual consumption of 5 or fewer alcoholic beverages / week
- Habitual consumption of 3 or fewer caffeinated beverages / day
Key exclusion criteria (18 listed)
- Present use of medication that may interfere with sleep or study drugs
- Travel across 3 or more time zones within 3 months of study start
- Habitual napping
- Extreme chronotype, determined by reduced Morningness-Eveningness Questionnaire (rMEQ) score: 8 < rMEQ > 21)
- Shift working within 2 weeks prior to the screening visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DMTNDexmedetomidine is a highly selective alpha-2 adrenergic receptor agonist that reduces the release of norepinephrine by inhibiting activity in the locus coeruleus, a key brain region involved in arousal and stress responses. In this study, dexmedetomidine will be administered as an oro-dispersible tablet applied buccally, allowing for rapid absorption through the oral mucosa. | Drug | High Dose, High Dose + Auditory Stimulation, Low Dose, Low Dose + Auditory Stimulation |
| Auditory StimulationAuditory tones will be presented throughout the night at individually calibrated intensities, adjusted to each participant's hearing threshold, in order to induce controlled sleep fragmentation without full awakenings. | Other | High Dose + Auditory Stimulation, Low Dose + Auditory Stimulation, Placebo + Auditory Stimulation |
| PlacboOro-dispersible placebo tablet identical in appearance and packaging to the active Dexmedetomidine tablet. | Drug | Placebo, Placebo + Auditory Stimulation |
Primary outcome
Change in Total Sleep Time (TST)
Time frame: Baseline Night, Experimental Night 1, Experimental Night 2, Experimental Night 3
The total amount of time spent in all sleep stages (N1, N2, N3, and REM) combined, measured in minutes.
Change in Wake After Sleep Onset (WASO)
Time frame: Baseline Night, Experimental Night 1, Experimental Night 2, Experimental Night 3
The total time spent awake in minutes after sleep has been initiated and before the final awakening.
Change in Sleep Efficiency
Time frame: Baseline Night, Experimental Night 1, Experimental Night 2, Experimental Night 3
The percentage of time spent asleep relative to the total time spent in bed (Total Sleep Time / Time in Bed * 100).
Change in Sleep Onset Latency (SOL)
Time frame: Baseline Night, Experimental Night 1, Experimental Night 2, Experimental Night 3
The time in minutes from "lights out" to the first epoch of any sleep stage.
Percentage of Time in N1, N2, N3 and REM-Sleep
Time frame: Baseline Night, Experimental Night 1, Experimental Night 2, Experimental Night 3
The proportion of Total Sleep Time spent in Stage N1, N2, N3 and REM-Sleep.
Change in Arousal Index
Time frame: Baseline Night, Experimental Night 1, Experimental Night 2, Experimental Night 3
The number of EEG arousals per hour of sleep.
Maximum Plasma Concentration (Cmax) of Dexmedetomidine
Time frame: Up to 24 hours post-dose on Experimental Night 1, Experimental Night 2, and Experimental Night 3
The maximum observed concentration of dexmedetomidine in plasma following administration, determined from serial blood sampling.
Time to Maximum Plasma Concentration (Tmax) of Dexmedetomidine
Time frame: Up to 24 hours post-dose on Experimental Night 1, Experimental Night 2, and Experimental Night 3
The time at which the maximum plasma concentration (Cmax) of dexmedetomidine is observed following administration.
Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Point (AUC0-t) of Dexmedetomidine
Time frame: Up to 24 hours post-dose on Experimental Night 1, Experimental Night 2, and Experimental Night 3
The cumulative drug exposure over time, calculated as the area under the dexmedetomidine plasma concentration versus time curve from the time of dosing to the last quantifiable plasma concentration.
Change in Plasma Noradrenaline Concentration
Time frame: Up to 24 hours post-dose on Experimental Night 1, Experimental Night 2, and Experimental Night 3
Assessment of the change in endogenous noradrenaline levels in plasma, measured from samples collected at predetermined timepoints following intervention.
16 secondary outcomes
Dim Light Melatonin Onset (DLMO)
Time frame: Evening after Experimental Night 1, Evening after Experimental Night 2, Evening after Experimental Night 3
Change in Autonomic Arousal Measured by Pupillometry
Time frame: Pre-dose, 15 minutes post-dose, 2 hours post-dose (only PK-Part), 4 hours post-dose (only PK-Part), 15 minutes after lights on.
Change in Heart Rate Variable
Time frame: Baseline Night, Experimental Night 1, Experimental Night 2, Experimental Night 3
Resting-state EEG spectral analysis
Time frame: Pre-sleep (evening) and post-sleep (morning) at the baseline night and each of the 3 overnight experimental visits (together with the "Change in Autonomic Arousal Measured by Pupillometry" acquisition).
Nocturnal thermoregulation
Time frame: Baseline Night, Experimental Night 1, Experimental Night 2, Experimental Night 3
Pre-sleep arousal levels (PSAS)
Time frame: Morning of Baseline Night, Morning of Experimental Night 1, Morning of Experimental Night 2, Morning of Experimental Night 3
Sedation depth (OAAS scale)
Time frame: Completed at each of the 3 overnight experimental visits similar to the blood sampling timepoints in the sleep opportunity window.
Mood states (POMS-16 and A-SIQ)
Time frame: Morning following Baseline Night, Morning following Experimental Night 1, Morning following Experimental Night 2, Morning following Experimental Night 3
State-Trait Anxiety Inventory (STAI)
Time frame: Morning following Baseline Night, Morning following Experimental Night 1, Morning following Experimental Night 2, Morning following Experimental Night 3
Psychomotor vigilance (PVT)
Time frame: Morning following Baseline Night, Morning following Experimental Night 1, Morning following Experimental Night 2, Morning following Experimental Night 3
Number of Participants with Orthostatic Intolerance as Defined by Schellong Test Criteria
Time frame: Morning following Baseline Night, Morning following Experimental Night 1, Morning following Experimental Night 2, Morning following Experimental Night 3
Number of Participants Exhibiting Clinically Significant Gait Instability During a Standardized Gait Task
Time frame: In the morning after 8 hours sleep opportunity window of the baseline night and each of the 3 overnight experimental visits. For the PK part additional timepoints (2 & 4 hours post dosing) will be measured during sleep opportunity window of 8 hours.
Change in Power of EEG Infra-Slow Oscillations (<0.1 Hz) During NREM Sleep
Time frame: Baseline Night, Experimental Night 1, Experimental Night 2, Experimental Night 3
Change in Blood Oxygen Saturation (SpO2)
Time frame: Continuously during each 3 of the the pharmacokinetic overnight experimental visits.
Change in Systolic Blood Pressure
Time frame: Evening and Morning of Baseline Night, Evening and Morning of Experimental Night 1, Evening and Morning of Experimental Night 2, Evening and Morning of Experimental Night 3
Change in Diastolic Blood Pressure
Time frame: Evening and Morning of Baseline Night, Evening and Morning of Experimental Night 1, Evening and Morning of Experimental Night 2, Evening and Morning of Experimental Night 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Paper of our previous research project, providing the background for the current studyLink provided by the sponsor.
- Individual participant dataSharing planned: No. Any disclosure of information to individuals not directly involved in the study must be approved by the owner of the data.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DMTN, Auditory Stimulation and Placbo in people with The Role of the LC-NA System in Sleep Regulation, run by Hans-Peter Landolt at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rafael Wespi, PhD (+41 44 635 59 61, rafael.wespi@pharma.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Sleep Time (TST) (time frame: Baseline Night, Experimental Night 1, Experimental Night 2, Experimental Night 3). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.