Parkinson DiseaseNCT05348837
Naturalistic Sleep Assessed by Wearable Devices in Parkinson Disease
An observational study of Parkinson Disease, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The cardinal motor features of Parkinson's disease (PD) include bradykinesia, rest tremor, and rigidity. Though non-motor features have been recognized for centuries, only recently has the prevalence and impact of non-motor symptoms become the focus of intense study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Deep brain stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing evaluation for DBS candidacy are eligible to participate in this study. Those deemed appropriate for DBS implantation and who undergo bilateral DBS will complete the second (post-operative) phase of the study. Candidacy for DBS implantation will be determined by the treating team, which includes a neurologist, neurosurgeon, neuropsychologist, neuro-radiologist, and palliative care physician. Decision to participate in the study will have no bearing on DBS candidacy. Patients are eligible to participate in this study regardless of device being implanted.
Who may be able to join
- Research subjects must be willing and able to do the following:
- Be able to learn to use and maintain a wristband-style sleep monitor
- Wear a wristband-style sleep monitor for two weeks
- Be able to learn to use and maintain a headband sleep monitor
- Wear a headband sleep monitor for two weeks
- Log daily routine events, such sleeping, eating, and medication regimens for the two-week study period
- Withhold dopaminergic medications after 5:00pm for three consecutive nights
Who cannot join
- Subjects will be excluded if they:
- Carry a diagnosis of dementia (e.g., Parkinson's Disease Dementia or Dementia with Lewy Bodies)
- Currently use or recently (within past 30 days) used a sedative-hypnotic agent for sleep (e.g., Zolpidem, Suvorexant, Eszopiclone)
- Fulfill criteria or carry a diagnosis of a circadian sleep-wake rhythm disorder, as defined by the International Classification of Sleep Disorders, Third Edition
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
The cardinal motor features of Parkinson's disease (PD) include bradykinesia, rest tremor, and rigidity. Though non-motor features have been recognized for centuries, only recently has the prevalence and impact of non-motor symptoms become the focus of intense study. Disturbances of sleep are among the most common non-motor manifestations of PD; approximately two-thirds of PD patients experience sleep dysfunction of some kind. Given that sleep contributes to the regulation of many physiological processes, sleep disturbance has a significant impact on quality of life in PD, and places high strain on caregivers. Though numerous symptomatic therapies exist, the treatment of sleep disorders in PD is limited by a lack of adequately powered, randomized studies providing high quality evidence. Although deep brain stimulation (DBS) is primarily used to treat PD motor symptoms and reduce the need for dopaminergic medications, several studies have shown that DBS provides benefit for non-motor symptoms, including sleep disturbance. Few studies have used an objective measure to assess the impact of DBS on sleep in PD, and none have done so by studying sleep in the home environment. Existing studies have largely been limited to a single night of sleep recording in a sleep lab. Furthermore, no studies have assessed sleep both on and off medication, before and after DBS implantation. This study will enroll patients undergoing evaluation for DBS implantation. Sleep will be assessed before DBS implantation, both while patients continue their usual medication regimen and while withholding medications. After DBS implantation and programming, sleep will again be assessed with stimulation on, both while continuing medications and subsequently while withholding medications.
- Conditions
- Parkinson Disease
- Being tested
- Deep brain stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulationProcedure or surgery
Candidacy for DBS implantation will be determined by the treating team, which includes a neurologist, neurosurgeon, neuropsychologist, neuro-radiologist, and palliative care physician.
| Study group | Role | What they receive |
|---|---|---|
| Subthalamic nucleus (STN) DBS | Patients undergoing evaluation for subthalamic nucleus DBS implantation will be included in this group. Receives: Procedure: Deep brain stimulation | |
| Globus pallidus interna (GPi) DBS | Patients undergoing evaluation for globus pallidus interna DBS implantation will be included in this group. Receives: Procedure: Deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total sleep time (TST) as measured by polysomnogram-capable headband
The total amount of time spent asleep, averaged over the 3-night study period, will be measured by a polysomnogram-capable headband (Dreem Headband, Rythm, France).
Measured: Baseline; 6 months
Secondary outcomes (7)
Change in sleep efficiency (SE) as measured by polysomnogram-capable headband
SE, defined as the amount of time spent asleep divided by the amount of time spent in bed, averaged over the 3-night study period, will be measured by a polysomnogram-capable headband (Dreem Headband, Rythm, France).
Measured: Baseline; 6 months
Change in sleep onset latency (SOL) as measured by polysomnogram-capable headband
SOL, defined as the amount of time between lying in bed to attempt to sleep and the onset of sleep, averaged over the 3-night study period, will be measured by a polysomnogram-capable headband (Dreem Headband, Rythm, France).
Measured: Baseline; 6 months
Change in wake after sleep onset (WASO) as measured by polysomnogram-capable headband
WASO, defined as the amount of time spent awake after the initial onset of sleep, averaged over the 3-night study period, will be measured by a polysomnogram-capable headband (Dreem Headband, Rythm, France).
Measured: Baseline; 6 months
Change in total sleep time (TST) as measured by actigraphy
Total amount of time spent asleep, averaged over the 3-night study period, will be measured by actigraphy
Measured: Baseline; 6 months
Change in sleep efficiency (SE) as measured by actigraphy
SE, defined as the amount of time spent asleep divided by the amount of time spent in bed, averaged over the 3-night study period, will be measured by actigraphy.
Measured: Baseline; 6 months
Change in sleep onset latency (SOL) as measured by actigraphy
SOL, defined as the amount of time between lying in bed to attempt to sleep and the onset of sleep, averaged over the 3-night study period, will be measured by actigraphy.
Measured: Baseline; 6 months
Change in wake after sleep onset (WASO) as measured by actigraphy
WASO, defined as the amount of time spent awake after the initial onset of sleep, averaged over the 3-night study period, will be measured by actigraphy.
Measured: Baseline; 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start1 May 2022
- Primary completion12 Sep 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Baumgartner, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348837
- Sponsor's protocol ID
- 22-0393
- Status last verified
- Nov 2026
- First submitted
- 21 Apr 2022
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naturalistic Sleep Assessed by Wearable Devices in Parkinson Disease
- ClinicalTrials.gov ID
- NCT05348837
- Acronym / sponsor ID
- 22-0393
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 12 Sep 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 27 Apr 2022 (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.
The cardinal motor features of Parkinson's disease (PD) include bradykinesia, rest tremor, and rigidity. Though non-motor features have been recognized for centuries, only recently has the prevalence and impact of non-motor symptoms become the focus of intense study. Disturbances of sleep are among the most common non-motor manifestations of PD; approximately two-thirds of PD patients experience sleep dysfunction of some kind. Given that sleep contributes to the regulation of many physiological processes, sleep disturbance has a significant impact on quality of life in PD, and places high strain on caregivers. Though numerous symptomatic therapies exist, the treatment of sleep disorders in PD is limited by a lack of adequately powered, randomized studies providing high quality evidence. Although deep brain stimulation (DBS) is primarily used to treat PD motor symptoms and reduce the need for dopaminergic medications, several studies have shown that DBS provides benefit for non-motor symptoms, including sleep disturbance. Few studies have used an objective measure to assess the impact of DBS on sleep in PD, and none have done so by studying sleep in the home environment. Existing studies have largely been limited to a single night of sleep recording in a sleep lab. Furthermore, no studies have assessed sleep both on and off medication, before and after DBS implantation. This study will enroll patients undergoing evaluation for DBS implantation. Sleep will be assessed before DBS implantation, both while patients continue their usual medication regimen and while withholding medications. After DBS implantation and programming, sleep will again be assessed with stimulation on, both while continuing medications and subsequently while withholding medications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subthalamic nucleus (STN) DBS | – | Procedure: Deep brain stimulationPatients undergoing evaluation for subthalamic nucleus DBS implantation will be included in this group. |
| Globus pallidus interna (GPi) DBS | – | Procedure: Deep brain stimulationPatients undergoing evaluation for globus pallidus interna DBS implantation will be included in this group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing evaluation for DBS candidacy are eligible to participate in this study. Those deemed appropriate for DBS implantation and who undergo bilateral DBS will complete the second (post-operative) phase of the study. Candidacy for DBS implantation will be determined by the treating team, which includes a neurologist, neurosurgeon, neuropsychologist, neuro-radiologist, and palliative care physician. Decision to participate in the study will have no bearing on DBS candidacy. Patients are eligible to participate in this study regardless of device being implanted.
Key inclusion criteria (7 listed)
- Be able to learn to use and maintain a wristband-style sleep monitor
- Wear a wristband-style sleep monitor for two weeks
- Be able to learn to use and maintain a headband sleep monitor
- Wear a headband sleep monitor for two weeks
- Log daily routine events, such sleeping, eating, and medication regimens for the two-week study period
Key exclusion criteria (4 listed)
- Carry a diagnosis of dementia (e.g., Parkinson's Disease Dementia or Dementia with Lewy Bodies)
- Currently use or recently (within past 30 days) used a sedative-hypnotic agent for sleep (e.g., Zolpidem, Suvorexant, Eszopiclone)
- Fulfill criteria or carry a diagnosis of a circadian sleep-wake rhythm disorder, as defined by the International Classification of Sleep Disorders, Third Edition
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 |
|---|---|---|
| Deep brain stimulationCandidacy for DBS implantation will be determined by the treating team, which includes a neurologist, neurosurgeon, neuropsychologist, neuro-radiologist, and palliative care physician. | Procedure or surgery | Globus pallidus interna (GPi) DBS, Subthalamic nucleus (STN) DBS |
Primary outcome
Change in total sleep time (TST) as measured by polysomnogram-capable headband
Time frame: Baseline; 6 months
The total amount of time spent asleep, averaged over the 3-night study period, will be measured by a polysomnogram-capable headband (Dreem Headband, Rythm, France).
7 secondary outcomes
Change in sleep efficiency (SE) as measured by polysomnogram-capable headband
Time frame: Baseline; 6 months
Change in sleep onset latency (SOL) as measured by polysomnogram-capable headband
Time frame: Baseline; 6 months
Change in wake after sleep onset (WASO) as measured by polysomnogram-capable headband
Time frame: Baseline; 6 months
Change in total sleep time (TST) as measured by actigraphy
Time frame: Baseline; 6 months
Change in sleep efficiency (SE) as measured by actigraphy
Time frame: Baseline; 6 months
Change in sleep onset latency (SOL) as measured by actigraphy
Time frame: Baseline; 6 months
Change in wake after sleep onset (WASO) as measured by actigraphy
Time frame: Baseline; 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Alexander Baumgartner, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by University of Colorado, Denver at 1 site in United States.
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 7 inclusion and 4 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: finished, as of the sponsor's last update on 5 Nov 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total sleep time (TST) as measured by polysomnogram-capable headband (time frame: Baseline; 6 months). 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 5 Nov 2026.