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

Not Applicable

Completed

• Conditions: Sleep Disorder

• Registration Number: NCT06937632
• Lead Sponsor: Alexandria University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2024-03-12
• Primary Completion: 2024-08-20
• Study Completion: 2024-09-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-05
• Study First Submitted QC: 2025-04-18
• Last Update Submitted: 2025-04-18
• Study First Posted: 2025-04-22
• Last Update Posted: 2025-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The Parkinson's Disease Sleep Scale (PDSS).	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 Outcome Measures

Name	Time	Method
Sleep Hygiene Index (SHI)	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.

Trial Locations

Locations (1)

Faculty of Nursing; 🇪🇬 Alexandria, Egypt