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NCT Number: NCT05348837

Naturalistic Sleep Assessed by Wearable Devices in Parkinson Disease

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Pamela Gerecht, PhD

CONTACT

[email protected]

303-724-4134

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep Brain Stimulation

Procedure

Candidacy for DBS implantation will be determined by the treating team, which includes a neurologist, neurosurgeon, neuropsychologist, neuro-radiologist, and palliative care physician.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Hirt

CONTACT

[email protected]

720-848-2080

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 27, 2022
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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