NCT06937632

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2024

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 22, 2025

Completed
Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

April 5, 2025

Last Update Submit

April 18, 2025

Conditions

Keywords

SleepSleep HygieneSleep QualityAgedParkinson's diseaseQuasi-Experimental Design

Outcome Measures

Primary Outcomes (1)

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

    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.

    3 month

Secondary Outcomes (1)

  • Sleep Hygiene Index (SHI)

    3 month

Study Arms (1)

interventional group

EXPERIMENTAL

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.

Behavioral: sleep hygiene intervention

Interventions

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.

interventional group

Eligibility Criteria

Age58 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Participants using sedative medications .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing

Alexandria, 21523, Egypt

Location

MeSH Terms

Conditions

Sleep Wake DisordersSleep HygieneSleep Initiation and Maintenance DisordersParkinson Disease

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersHealth BehaviorBehaviorSleep Disorders, IntrinsicDyssomniasParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Rasha Eweida

Study Record Dates

First Submitted

April 5, 2025

First Posted

April 22, 2025

Study Start

March 12, 2024

Primary Completion

August 20, 2024

Study Completion

September 1, 2024

Last Updated

April 22, 2025

Record last verified: 2025-04

Locations