Sleep DisorderNCT06937632
Sleep Hygiene Intervention on Sleep Quality Improvement in Elders With Parkinson's Disease
A study testing sleep hygiene intervention in people with Sleep Disorder, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 58 to 60 years
- Conditions the study is for
- Sleep Disorder
- What is being tested?
- sleep hygiene intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Mar 2024to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 58 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Elderly individuals aged 60 years or older, with a confirmed diagnosis of Parkinson's Disease.
- Cognitively and physically able to engage in the study.
Who cannot join
- Participants using sedative medications .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Nurse-Led Sleep Hygiene Intervention on Sleep Quality Improvement in Elders With Parkinson's Disease: A Quasi-experimental Research Design
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.
Read the 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.
- Conditions
- Sleep Disorder
- Being tested
- sleep hygiene intervention
- Keywords
- Sleep, Sleep Hygiene, Sleep Quality, Aged, Parkinson's disease, Quasi-Experimental Design
- Medical subject headings
- Sleep Wake Disorders, Sleep Hygiene, Sleep Initiation and Maintenance Disorders, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep hygiene interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: sleep hygiene intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 month
Secondary outcomes (1)
Sleep Hygiene Index (SHI)
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.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start12 Mar 2024
- Primary completion20 Aug 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha salah elsayed eweida, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937632
- Sponsor's protocol ID
- 4/4/2025
- Status last verified
- Apr 2025
- First submitted
- 5 Apr 2025
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Nurse-Led Sleep Hygiene Intervention on Sleep Quality Improvement in Elders With Parkinson's Disease: A Quasi-experimental Research Design
- ClinicalTrials.gov ID
- NCT06937632
- Acronym / sponsor ID
- 4/4/2025
- Conditions
- Sleep Disorder
- Keywords
- Sleep, Sleep Hygiene, Sleep Quality, Aged, Parkinson's disease, Quasi-Experimental Design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| interventional group | Experimental | Behavioral: sleep hygiene interventionsleep 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. |
Who may qualify
- Ages
- 58 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Elderly individuals aged 60 years or older, with a confirmed diagnosis of Parkinson's Disease.
- Cognitively and physically able to engage in the study.
Key exclusion criteria (1 listed)
- Participants using sedative medications .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sleep hygiene interventionsleep 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. | Behavioural | interventional group |
Primary outcome
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.
1 secondary outcome
Sleep Hygiene Index (SHI)
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sleep hygiene intervention in people with Sleep Disorder, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Parkinson's Disease Sleep Scale (PDSS). (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.