* To assess effect of zolpidem compared to placebo on walking (adapt)ability in healthy elderly as measured by the Interactive Walkway. * To assess effect of suvorexant compared to placebo on walking (adapt)ability in healthy elderly as measured by…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Biomarker . Methodology
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pharmacodynamic endpoints
The Interactive Walkway takes approximately 15 minutes and includes the
following tests:
* 8-meter walking test. Walking at a self-selected walking speed. The outcome
measures are walking speed (cm/s), step length (cm), step width (cm), cadence
(steps/min), and step time (s). The test has a duration of approximately 1-2
minutes.
* Obstacle avoidance. Avoiding suddenly appearing obstacles. The outcome
measures are obstacle-avoidance margins (cm), success rate (%), and
(normalized) walking speed (%). The test has a duration of approximately 4-5
minutes.
* Goal-directed stepping. Stepping as accurately as possible onto the
shoe-size-matched steppingstones placed in an irregular pattern. The outcome
measures are stepping accuracy (cm) and (normalized) walking speed (%). The
test has a duration of approximately 1-2 minutes.
* Tandem walking. Walking on a line. The outcome measures are success rate (%),
(normalized) walking speed (%), and mediolateral sway (cm). The test has a
duration of approximately 1-2 minutes.
* Timed Up-and-Go test. Rising from a standard armchair, walking to a line on
the floor 3 meters away, turning, returning, and sitting down again. The
outcome measures is time (s). The test has a duration of approximately 3-4
minutes.
The NeuroCart for this study includes the following tests:
* Body Sway. This test assesses postural stability. The outcome measure is sway
(mm). The test has a duration of approximately 2 minutes.
* Adaptive Tracker. This test assesses pursuit-tracking. The outcome measure is
success rate (%) The test has a duration of approximately 3 minutes.
The Withings Steel HR smartwatch includes the following tests:
* Step count
* Heart rate
* Sleep pattern (time it takes to fall asleep, sleep duration, sleep cycles and
sleep interruptions)
* Physical activity duration
Pharmacokinetic endpoints
PK parameters of suvorexant and zolpidem by non-compartmental analysis of the
plasma concentration-time data:
Maximum concentration (Cmax), Time to attain Cmax (Tmax), Area under the
concentration * time curve (AUClast), Terminal Elimination Half-life (t1/2).
Tolerability and safety endpoints
Adverse events and vital signs measurements.
Secondary outcome
NA
Background summary
Dynamic assessments like walking adaptability may yield a stronger predictor
for falls, as falls predominantly occur during walking and transfers that
demand gait adjustment. Previous studies have shown most walking-related falls
result from inadequate interactions with environmental context, leading to
balance loss due to a trip, slip or misplaced step14. Walking adaptability thus
seems to be an important determinant of fall risk.
The Interactive Walkway is an instrument developed to assess walking
adaptability by augmenting a multi-Kinect-v2 10-m walkway with gait-dependent
visual context (stepping targets, obstacles) using real-time processed
markerless full-body kinematics15,16. Measurement of walking adaptability using
the Interactive Walkway includes the ability to avoid obstacles, make sudden
stops and starts and accurately place the feet to environmental context.
Study objective
* To assess effect of zolpidem compared to placebo on walking (adapt)ability in
healthy elderly as measured by the Interactive Walkway.
* To assess effect of suvorexant compared to placebo on walking (adapt)ability
in healthy elderly as measured by the Interactive Walkway.
* To compare the effect of suvorexant with the effect of zolpidem on walking
(adapt)ability in the first three hours after drug administration.
* To explore the influence of smartwatch-based night-time sleep on Interactive
Walkway and NeuroCart endpoints.
* To explore the validity of a smartwatch-based Timed Up and Go model.
* Optional. To establish the relationship between walking (adapt)ability
parameters, Body Sway, and Adaptive Tracker.
Study design
This study is a randomized, double-blind, placebo-controlled, three-way
crossover pilot study to evaluate the effect of suvorexant 10 mg and zolpidem 5
mg on walking (adapt)ability in 18 healthy elderly volunteers.
Intervention
Suvorexant 10 mg
Zolpidem 5 mg
Placebo
Study burden and risks
Participation in this trial is without any (therapeutic) benefit for healthy
subjects. Their participation, however, is of importance for the understanding
of the effects on walking (adapt)ability of orexin antagonists as a relatively
new class of medication for insomnia in an elderly population. Both suvorexant
and zolpidem are expected to have sleep inducing effects. Symptoms such as
somnolence, fatigue, reduced vigilance, dizziness, etc., are therefore expected
following administration. The burden for the subjects is expected to be minimal
given the time input and none invasive measurements. Conducting this study
with elderly subjects makes this study clinically more relevant due to the
higher risk of falling with more severe complications as a result in this
population, as well as the high number of prescriptions for sleep-inducing
medications in elderly.
Zernikedreef 8
Leiden 2333CL
NL
Zernikedreef 8
Leiden 2333CL
NL
Listed location countries
Age
Inclusion criteria
1. Male and female subjects aged between 65 years and 80 years (inclusive) at
screening.
2. Body mass index (BMI) within the range of 18 to 30 kg/m2 (inclusive) at
screening.
3. Systolic blood pressure 100-160 mmHg, diastolic blood pressure 50-95 mmHg,
and pulse rate 45-100 bpm (inclusive), measured on either arm, after 5 min in
the supine position at screening.
4. Estimated creatinine clearance (using the Cockcroft &Gault formula) *60
mL/min to allow for some reduced renal function in the elderly.
5. Subject has a regular sleep pattern (bedtime between 22:00 and 00:30 and
sleep for at least 6 h).
Exclusion criteria
1. Hypersensitivity to benzodiazepines and/ or meeting contraindication
criteria for zolpidem: myasthenia gravis, sleep apnea syndrome, liver failure,
respiratory depression.
2. Hypersensitivity to orexin antagonist and/ or meeting contraindication
criteria for suvorexant: narcolepsy.
3. Regular use of sedative/hypnotic drugs.
4. Regular use of walking aids.
5. Recurrent fallers defined as > 3 falls per year.
6. Neurological diseases and/or orthopedic problems interfering with gait
function
7. Mini Mental State Examination score < 25 at Screening.
8. Current or previous diagnosis of insomnia-related disorder according to the
Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5)
criteria.
9. Vaccination for SARS-CoV-2 within 4 days of screening and/or dosing with
study drug.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-000322-10-NL |
| CCMO | NL76600.056.21 |
| OMON | NL-OMON25974 |