Naturalistic Sleep Assessed by Wearable Devices in Parkinson Disease

• ClinicalTrials.gov Identifier: NCT05348837
• Recruitment Status: Recruiting
• First Posted: April 27, 2022
• Last Update Posted: August 12, 2022
• Sponsor: University of Colorado, Denver
• Information provided by (Responsible Party): University of Colorado, Denver

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment
Parkinson Disease	Procedure: Deep brain stimulation

Study Design

• Study Type: Observational
• Estimated Enrollment: 15 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Naturalistic Sleep Assessed by Wearable Devices in Parkinson Disease
• Actual Study Start Date: May 1, 2022
• Estimated Primary Completion Date: May 2023
• Estimated Study Completion Date: August 2023

Groups and Cohorts

Group/Cohort	Intervention/treatment
Subthalamic nucleus (STN) DBS; Patients undergoing evaluation for subthalamic nucleus DBS implantation will be included in this group.	Procedure: Deep brain stimulation; Candidacy for DBS implantation will be determined by the treating team, which includes a neurologist, neurosurgeon, neuropsychologist, neuro-radiologist, and palliative care physician.
Globus pallidus interna (GPi) DBS; Patients undergoing evaluation for globus pallidus interna DBS implantation will be included in this group.	Procedure: Deep brain stimulation; Candidacy for DBS implantation will be determined by the treating team, which includes a neurologist, neurosurgeon, neuropsychologist, neuro-radiologist, and palliative care physician.

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. Change in sleep efficiency (SE) as measured by polysomnogram-capable headband [ Time Frame: Baseline; 6 months ]
   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).
2. Change in sleep onset latency (SOL) as measured by polysomnogram-capable headband [ Time Frame: Baseline; 6 months ]
   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).
3. Change in wake after sleep onset (WASO) as measured by polysomnogram-capable headband [ Time Frame: Baseline; 6 months ]
   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).
4. Change in total sleep time (TST) as measured by actigraphy [ Time Frame: Baseline; 6 months ]
   Total amount of time spent asleep, averaged over the 3-night study period, will be measured by actigraphy
5. Change in sleep efficiency (SE) as measured by actigraphy [ Time Frame: Baseline; 6 months ]
   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.
6. Change in sleep onset latency (SOL) as measured by actigraphy [ Time Frame: Baseline; 6 months ]
   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.
7. Change in wake after sleep onset (WASO) as measured by actigraphy [ Time Frame: Baseline; 6 months ]
   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.

Other Outcome Measures:

1. Change in Pittsburgh Sleep Quality Index (PSQI) score [ Time Frame: Baseline; 6 months ]
   The PSQI is a well-validated clinical questionnaire that queries subjects on seven sleep parameters.
2. Change in Parkinson Disease Sleep Scale, version 2 (PDSS-2) score [ Time Frame: Baseline; 6 months ]
   The PDSS-2 is a 15-item scale which specifically queries several sleep disturbances commonly afflicting PD patients, including restless leg syndrome, nocturia, pain, and sleep apnea
3. Change in Fatigue Severity Scale (FSS) score [ Time Frame: Baseline; 6 months ]
   The FSS is a nine-item scale that measures the severity of fatigue and its impact on daily life.
4. Change in Epworth Sleepiness Scale (ESS) score [ Time Frame: Baseline; 6 months ]
   The ESS is a self-administered, eight-item assessment of daytime sleepiness.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Contacts

Contact: Alexander Baumgartner, MD; 720-848-2080; alexander.baumgartner@cuanschutz.edu

Locations

United States, Colorado

University of Colorado Anschutz Medical Campus; Recruiting

Aurora, Colorado, United States, 80045

Contact: Pamela Gerecht, PhD 303-724-4134 pamela.davidgerecht@cuanschutz.edu

Sponsors and Collaborators

University of Colorado, Denver

Investigators

• Principal Investigator: Alexander Baumgartner, MD; University of Colorado - Anschutz Medical Campus

More Information

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT05348837
• Other Study ID Numbers: 22-0393
• First Posted: April 27, 2022
• Last Update Posted: August 12, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases