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Completed

NCT Number: NCT06937632

Sleep Hygiene Intervention on Sleep Quality Improvement in Elders With Parkinson's Disease

Sleep disorders (SDs) are one of the most frequent non-motor symptoms of Parkinson's disease (PD), usually increasing in frequency over the course of the disease and disability progression. SDs include nocturnal and diurnal manifestations such as insomnia, REM sleep behavior disorder, and excessive daytime sleepiness. The causes of SDs in PD are numerous, including the neurodegeneration process itself, which can disrupt the networks regulating the sleep-wake cycle and deplete a large number of cerebral amines possibly playing a role in the initiation and maintenance of sleep.

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Key information

Conditions

Sleep Disorder Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Dyssomnias Health Behavior Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Hygiene Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Synucleinopathies

Age range

58 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Nursing

Alexandria, 21523, Egypt

About this study

Sleep disorders (SDs) constitute the second most frequent complaint, affecting 64% of PD patients, ranging from 41.1% in naïve patients to 78.3% in complicated patients. SDs in PD are multifactorial and include nocturnal and diurnal manifestations. Reduced sleep efficiency and an increased number of awakenings characterize sleep in PD. These disturbances are linked, on one side, to PD motor (akinesia, rigidity, and dystonia) and autonomic symptoms (nocturia) and, on the other side, to the presence of concomitant SDs such as REM sleep behavior disorder (RBD), restless legs syndrome (RLS), or breathing disorders such as obstructive sleep apnea (OSA). Diurnal manifestations include excessive daytime sleepiness (EDS) and sudden sleep attacks, which could be a consequence of nocturnal sleep impairment or dopaminergic treatment or, more interestingly, to the neurodegenerative process of PD itself dysregulating the circadian sleep-wake rhythm.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Elderly individuals aged 60 years or older, with a confirmed diagnosis of Parkinson's Disease.
  • Cognitively and physically able to engage in the study.

Exclusion criteria

  • Participants using sedative medications .

Treatment and study plan

Sleep hygiene intervention

Behavioral

sleep program was done three times a week for 2 weeks for the study group (6 sessions in total). It took roughly 30 minutes for each session. sessions were demonstrated during the first 3 sessions, re-demonstration of all the 3 of other sessions. Over a course of two sessions, the older adults in the intervention group were taught how to perform sleep program. The telephone number of each subject was taken to check their consistency with the proposed nursing interventions.

Primary outcomes

  1. The Parkinson's Disease Sleep Scale (PDSS).

    Time frame: 3 month

    The Parkinson's Disease Sleep Scale (PDSS) was developed by (Chaudhuri et al 2002) to assess sleep quality for patients with Parkinson's disease. The scoring system of PDSS scale is:0-30 very poor sleep, 31- 60 poor, 61- 90 neutral, 91- 120 good, 121- 150 very good sleep.

Secondary outcomes

  1. Sleep Hygiene Index (SHI)

    Time frame: 3 month

    Sleep Hygiene Index was developed by (Mastin et al 2006). The Sleep Hygiene Index is a 13 item self-administered index used to assess the presence of behaviors that are thought to compromise sleep quality. The scoring system of (SHI) is: 0-12 very good sleep hygiene, 13- 26 good, 27- 40 poor, 41- 52 very poor sleep hygiene.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Effect of a Nurse-Led Sleep Hygiene Intervention on Sleep Quality Improvement in Elders With Parkinson's Disease: A Quasi-experimental Research Design

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 22, 2025
Registry last updated
Apr 22, 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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