InsomniaNCT06249607
Impact Of Mindfulness Breathing Versus Storytelling On Non- Specific Insomnia In Elderly
A study testing storytelling, Mindfulness breathing and Sleep hygiene in people with Insomnia and Sleep Disorder, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to compare between effects of mindfulness breathing and storytelling on insomnia in the elderly. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Insomnia, Sleep Disorder
- What is being tested?
- storytelling, Mindfulness breathing and Sleep hygiene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2024to 5 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients who have non-specific insomnia for one month at least.
- Their ages > 65 years.
- Medically stable patients.
- Current complaint of poor SQ (score > 5 of the SQ scale)
- Body mass index ≤ 35 kg/m2.
Who cannot join
- Patients having a well-structured diagnosis of relevant brain illness or
- any disease directly affects sleep.
- Any patient with unstable medical condition
- History of chronic insomnia
- Indication of receiving treatments for depression and anxiety
- Hearing problem
Trial locations and contacts
1 site in 1 country.
About this study
This study will be conducted to compare between effects of mindfulness breathing and storytelling on insomnia in the elderly.
Read the detailed description
Sufficient sleep is essential for optimum health just a few of the numerous processes occurring during sleep include memory consolidation, clearance of brain metabolites, and restoration of nervous, immune, skeletal, and muscular systems. Despite the significance of adequate sleep, insufficient or disturbed sleep is extremely common. For instance, thirty percent of employed adults report obtaining 6 or fewer hours of sleep per night, approximately one-third of all adults report significant sleep complaints, and the two most common sleep disorders, insomnia and sleep-disordered breathing (SDB), each have prevalence rates exceeding 10% in the adult population. Unfortunately, current approaches to treatment are limited .
Story telling is another common soothing bedtime routine for children that uses pictures and writing. It is also a nursing intervention that can be implemented to comfort hospitalized children with acute illness and increase enthusiasm. Story telling is a recommended activity that enhances sleep duration in children. Furthermore, it is considered a positive bedtime routine, in addition to praying and brushing teeth, compared to maladaptive bedtime routine, such as watching television, playing with gadgets, and playing games with high-level activities .
- Conditions
- Insomnia, Sleep Disorder
- Being tested
- storytelling, Mindfulness breathing, Sleep hygiene
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
storytellingOther
Storytelling android program: Subjects in group A or the storytelling group will be given headphones to listen to stories for 30 min (i.e., between 9 and 10 pm). While the subject listens to the story, a relative will present in a corner of the room to record when they fell asleep, the relative will present again in the room to record the time of falling asleep. The intervention will be done 7 nights a week for a period of 6 weeks.
Mindfulness breathingOther
android program: Individuals in group B are instructed to "sit upright in a comfortable position with eyes closed," "focus on diaphragm movements while breathing in a slow, deep, relaxed manner," and to nonjudgmentally acknowledge and accept "unwanted thoughts, ideas or images" and "return attention to the diaphragmatic breathing. In this exercise, individuals are instructed to notice the physical sensations of breathing, both inhalations and exhalations, with a focus on the natural rate of respiration as opposed to forcibly controlling the breath. Duration: 5 minutes in duration per session, before sleep for 7 days a week for a total duration of 6 weeks
Sleep hygieneOther
Subjects in all groups will receive tips about healthy sleep
- Maintain a regular sleep routine.
- Avoid daytime naps.
- Don't stay in bed awake for more than 5-10 minutes.
- Don't watch TV, use the computer, or read in bed.
- Drink caffeinated drinks with caution.
- Avoid inappropriate substances that interfere with sleep.
- Clean fresh air.
- Have a quiet, comfortable bedroom.
| Study group | Role | What they receive |
|---|---|---|
| Group A: combined sleep hygiene and storytelling | Experimental | Not described Receives: Other: storytelling; Other: Sleep hygiene |
| Group B: combined sleep hygiene and mindfulness breathing exercise group | Experimental | Not described Receives: Other: Mindfulness breathing; Other: Sleep hygiene |
| Group C: sleep hygiene group | Other | Not described Receives: Other: Sleep hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index (PSQI) as a valid tool was used to measure the patients' SQ. This instrument was comprised of seven domains, including quality of subjective sleep, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, daytime dysfunction, and use of medication for sleep over the previous month. The score of the domains ranged from 0 = "No difficulty" to 3 = "Severe difficulty". A total score > 5 was considered to be indicative of poor SQ. A global score between 0 and 21 was derived by summing up the seven subscale scores
Measured: baseline
Actigraphy
Actigraph (Actiwatch Minimitter Company, INC - Sunriver, OR, USA) will be placed on the non-dominant wrist and activities will be monitored continuously and recorded at one minute intervals during wakefulness and sleep.
The times of wakefulness and sleep will be determined individually through a diary kept by the volunteers, together with the times calculated by the actigraph monitor.
The participants will keep the device for a period of 7 days before the first and the last training session. The device will be removed only at bath time and replaced to the wrist immediately after.
The information will be collected by the device and recorded by a validated algorithm (Minimitter Company - USA®) and transferred to a closed technology software installed on a computer.
After analysis of the exams, the data will be plotted on a spreadsheet for statistical treatment
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start5 Jan 2024
- Primary completion1 Sep 2024
- Study completion5 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Abubaker Rabiee, Cairo University
- Investigators
- mohamed abubakr rabiee, PhD, Principal investigator, physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249607
- Sponsor's protocol ID
- MindfulnessBreathing,Insomnia
- Status last verified
- Sep 2024
- First submitted
- 28 Sep 2023
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Of Mindfulness Breathing Versus Storytelling On Non- Specific Insomnia In Elderly
- ClinicalTrials.gov ID
- NCT06249607
- Acronym / sponsor ID
- MindfulnessBreathing,Insomnia
- Conditions
- Insomnia, Sleep Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 8 Feb 2024 (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.
This study will be conducted to compare between effects of mindfulness breathing and storytelling on insomnia in the elderly.
Detailed description
Sufficient sleep is essential for optimum health just a few of the numerous processes occurring during sleep include memory consolidation, clearance of brain metabolites, and restoration of nervous, immune, skeletal, and muscular systems. Despite the significance of adequate sleep, insufficient or disturbed sleep is extremely common. For instance, thirty percent of employed adults report obtaining 6 or fewer hours of sleep per night, approximately one-third of all adults report significant sleep complaints, and the two most common sleep disorders, insomnia and sleep-disordered breathing (SDB), each have prevalence rates exceeding 10% in the adult population. Unfortunately, current approaches to treatment are limited .
Story telling is another common soothing bedtime routine for children that uses pictures and writing. It is also a nursing intervention that can be implemented to comfort hospitalized children with acute illness and increase enthusiasm. Story telling is a recommended activity that enhances sleep duration in children. Furthermore, it is considered a positive bedtime routine, in addition to praying and brushing teeth, compared to maladaptive bedtime routine, such as watching television, playing with gadgets, and playing games with high-level activities .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: combined sleep hygiene and storytelling | Experimental | Other: storytelling, Other: Sleep hygiene |
| Group B: combined sleep hygiene and mindfulness breathing exercise group | Experimental | Other: Mindfulness breathing, Other: Sleep hygiene |
| Group C: sleep hygiene group | Other | Other: Sleep hygiene |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patients who have non-specific insomnia for one month at least.
- Their ages > 65 years.
- Medically stable patients.
- Current complaint of poor SQ (score > 5 of the SQ scale)
- Body mass index ≤ 35 kg/m2.
Key exclusion criteria (6 listed)
- Patients having a well-structured diagnosis of relevant brain illness or
- any disease directly affects sleep.
- Any patient with unstable medical condition
- History of chronic insomnia
- Indication of receiving treatments for depression and anxiety
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 |
|---|---|---|
| storytellingStorytelling android program: Subjects in group A or the storytelling group will be given headphones to listen to stories for 30 min (i.e., between 9 and 10 pm). While the subject listens to the story, a relative will present in a corner of the room to record when they fell asleep, the relative will present again in the room to record the time of falling asleep. The intervention will be done 7 nights a week for a period of 6 weeks. | Other | Group A: combined sleep hygiene and storytelling |
| Mindfulness breathingandroid program: Individuals in group B are instructed to "sit upright in a comfortable position with eyes closed," "focus on diaphragm movements while breathing in a slow, deep, relaxed manner," and to nonjudgmentally acknowledge and accept "unwanted thoughts, ideas or images" and "return attention to the diaphragmatic breathing. In this exercise, individuals are instructed to notice the physical sensations of breathing, both inhalations and exhalations, with a focus on the natural rate of respiration as opposed to forcibly controlling the breath. Duration: 5 minutes in duration per session, before sleep for 7 days a week for a total duration of 6 weeks | Other | Group B: combined sleep hygiene and mindfulness breathing exercise group |
| Sleep hygieneSubjects in all groups will receive tips about healthy sleep * Maintain a regular sleep routine. * Avoid daytime naps. * Don't stay in bed awake for more than 5-10 minutes. * Don't watch TV, use the computer, or read in bed. * Drink caffeinated drinks with caution. * Avoid inappropriate substances that interfere with sleep. * Clean fresh air. * Have a quiet, comfortable bedroom. | Other | Group A: combined sleep hygiene and storytelling, Group B: combined sleep hygiene and mindfulness breathing exercise group, Group C: sleep hygiene group |
Primary outcome
The Pittsburgh Sleep Quality Index
Time frame: baseline
Pittsburgh Sleep Quality Index (PSQI) as a valid tool was used to measure the patients' SQ. This instrument was comprised of seven domains, including quality of subjective sleep, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, daytime dysfunction, and use of medication for sleep over the previous month. The score of the domains ranged from 0 = "No difficulty" to 3 = "Severe difficulty". A total score > 5 was considered to be indicative of poor SQ. A global score between 0 and 21 was derived by summing up the seven subscale scores
Actigraphy
Time frame: baseline
Actigraph (Actiwatch Minimitter Company, INC - Sunriver, OR, USA) will be placed on the non-dominant wrist and activities will be monitored continuously and recorded at one minute intervals during wakefulness and sleep. The times of wakefulness and sleep will be determined individually through a diary kept by the volunteers, together with the times calculated by the actigraph monitor. The participants will keep the device for a period of 7 days before the first and the last training session. The device will be removed only at bath time and replaced to the wrist immediately after. The information will be collected by the device and recorded by a validated algorithm (Minimitter Company - USA®) and transferred to a closed technology software installed on a computer. After analysis of the exams, the data will be plotted on a spreadsheet for statistical treatment
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 25 Sep 2024.
- ABCs of SLEEPING: A review of the evidence behind pediatric sleep practice recommendationsLink provided by the sponsor.
Related trials for Insomnia
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
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.
mohamed abubakr rabiee, PhD principal investigator
physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing storytelling, Mindfulness breathing and Sleep hygiene in people with Insomnia and Sleep Disorder, run by Cairo 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 5 inclusion and 6 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 25 Sep 2024. 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 Pittsburgh Sleep Quality Index (time frame: baseline). The study lists 2 primary outcomes in all. 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 25 Sep 2024.