Idiopathic ScoliosisNCT05288972
The Effect of Different Mattress Types on Sleep Quality in Adult Individuals With Idiopathic Scoliosis
A study testing Mattress 1 and Mattress 2 in people with Idiopathic Scoliosis and Sleep, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Objective: The aim of this study is to investigate the effect of different mattress materials on sleep behavior in adults with idiopathic scoliosis treated with non-invasive techniques. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Idiopathic Scoliosis, Sleep
- What is being tested?
- Mattress 1 and Mattress 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Apr 2022to 15 Mar 2023
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with idiopathic scoliosis
- Cobb angle between 10 and 50 degrees
- Age 18-45 years
- Last mattress use period > 6 months
Who cannot join
- Surgical history (last 2 years)
- Lung problems, chronic respiratory or neuromuscular disease,
- Back Depression Scale score ≥ 17 \& taking antidepressants
- Insomnia Severity Index score ≥ 7 \& Using sleeping pills/hormones
- Diagnosed with a sleep disorder (history of restless sleep, sleep apnea…)
- Non-vertebral pain that affects sleep behavior
Show all 9Show fewer
- Presence of a newly developed condition in the last 6 months that will affect sleep quality
- A change in the conservative treatment for scoliosis in the last 3 months, or a change is planned
- BMI <18.5 or >30 kg/m2
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Cerrahpasa, Faculty of Health Science
Istanbul
About this study
Official title: The Effect of Different Mattress Types on Sleep Quality, Pain, Fatigue, Physical Adaptation, Functional Status, and Quality of Life in Adult Individuals With Idiopathic Scoliosis
Objective: The aim of this study is to investigate the effect of different mattress materials on sleep behavior in adults with idiopathic scoliosis treated with non-invasive techniques.
Hypothesis 0: The use of a mattress that supports the spine properly, together with sleep accessories such as pillows, does not affect sleep behavior, does not alleviate back pain, and does not affect overall sleep quality and duration in adults with scoliosis.
Read more
Hypothesis 1: The use of a mattress that supports the spine properly, along with sleep accessories such as pillows, affects sleep behavior, helps relieve back pain, and affects overall sleep quality and duration in adults with scoliosis.
Possible outcomes: Improving sleep behavior and supporting the quality of life of individuals with idiopathic scoliosis.
Read the detailed description
Scoliosis, which is characterized by the curvature of the spine to the right or left, is a common orthopedic problem today. Due to the restriction of mobility and various symptoms of the disease, people may experience difficulties in their daily lives. The clinical manifestation of scoliosis in adults is most often characterized by the presence of back pain. Unbalanced, overloaded, and strained back muscles are under constant pressure and contribute greatly to back pain. The pain may be localized at the apex of the curve (apex) or around the concavity or may radiate down the leg. This can affect people's fatigue, physical adaptation, functional status, and quality of life. This study aims to examine sleep behavior and to investigate the effects of different mattress materials on pain, sleep quality, fatigue, physical adaptation, functional status, and quality of life in adults with idiopathic scoliosis treated with non-invasive techniques.
Voluntary participants who have been diagnosed with idiopathic scoliosis will be included in the study. Signed voluntary consent will be obtained from participants. The participants will be divided into 2 groups by block randomization according to the curve type and severity and will be evaluated as double-blind.
The first group will be given a mattress (M1) with the technical features suitable for scoliosis with supports the spine properly, and the control group will be given a mattress with standard technical features (M2). The mattresses will use for 4 weeks, at least 5 days a week, including at least 6 hours of sleep per day.
- Conditions
- Idiopathic Scoliosis, Sleep
- Being tested
- Mattress 1, Mattress 2
- Keywords
- spine, scoliosis, mattress, fatique, pain, quality of life
- Medical subject headings
- Scoliosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mattress 1Device
A mattress (M1) with the technical features suitable for scoliosis with supports the spine properly. The mattress will use for 4 weeks, at least 5 days a week, including at least 6 hours of sleep per day.
Mattress 2Device
A mattress with standard technical features (M2). The mattress will use for 4 weeks, at least 5 days a week, including at least 6 hours of sleep per day.
| Study group | Role | What they receive |
|---|---|---|
| Mattress 1 | Experimental | Mattress 1 group will receive Polyurethane, Bonnel spring, medium-hard mattress Receives: Device: Mattress 1 |
| Mattress 2 | Active comparator | Mattress 2 group will receive Polyurethane, pocket spring, medium mattress Receives: Device: Mattress 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self Reported Sleep Quality
Pittsburgh Sleep Quality Scale: It is a 19-item self-report scale that evaluates sleep quality and disturbance in the past month. Each item of the test is scored equally between 0-3. The scale consists of 7 subscales that assess subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disorders, use of sleep medication, and loss of daytime functionality. By summing up the subscales, a total score ranging from 0 to 21 is obtained. A total score greater than five, with 89.6% sensitivity and 86.5% specificity, indicates inadequate sleep quality and indicates severe impairment in at least two of the above-mentioned areas or moderate impairment in three areas.
Measured: 4 weeks
Sleep Quality with Wearable Actigraph
Wearable Actigraph: The wearable actigraphs to be used in the study are small, lightweight, portable devices that can be worn in the form of a watch, measuring sleep and wake cycles, and sensitively detecting motor activities.
In the study, wearable sleep actigraphs (Actigraph wgt3x-bt) will be used by attaching them to the non-dominant wrists of the participants, thus enabling the recording and storage of resting and activity patterns in a digital environment. Each participant will be asked to wear the wearable sleep actigraph in the form of a watch for 7 days (5 weekdays and 2 weekend days) during the last week of the study, and sleep data will be recorded. The recorded data will be transferred to the computer and after the transfer, the device will be reformatted and prepared for new recordings.
Measured: 1 week
Sleep Quality with Non-Wearable Actigraph
Non-Wearable Actigraph: Non-wear actigraphs (Reston Z200) to be used in the study are made ready for use by laying them on the bed. While the cord of the device is laid inside the bed, the device is suspended from the side of the bed. Bed linen is placed on it. Thus, it does not disturb the person during sleep. Each participant will be asked to use the no-wear sleep actigraph laid on their bed every day (5 weekdays and 2 weekend days) throughout the study (4 weeks). With a free application installed on the smartphone, 30 days of sleep data will be recorded.
Measured: 4 weeks
Secondary outcomes (10)
Subjective Feedback Inquiry
Subjective Feedback Questionnaire: It consists of questions such as the feeling of comfort in nine body regions (neck, shoulder, back, elbows, waist, hand/wrist, hip/thigh, knee, ankle), feeling of firmness, preference for bed, preference for sinking-buried. It will be marked on a 5-point Likert scale. Scoring is done between 0-5 for each. The higher the score represents better comfort.
Measured: 4 weeks
Pain intensity
Visual Analog Scale (VAS): Patients will be asked to mark the degree of pain they feel at rest, in motion, and at night on the 10 cm VAS line. The condition that there is no pain is expressed as 0, and the condition that there is too much pain to be tolerated is expressed as 10. Subjects are asked to rate the pain they feel in their back/waist in the evening (before going to bed), at night (sleeping), in the morning (when getting out of bed in the morning), during the day (during the day). High scores indicate an increasing degree of pain.
Measured: 4 weeks
Musculoskeletal Discomfort
Cornell Musculoskeletal Questionnaire (CMQ): It's a 54-item questionnaire and involves a self-rating of the frequency, severity, and work interference of the musculoskeletal discomfort on three scales across 20 body parts. On the frequency scale, the frequency of experiencing musculoskeletal discomfort in the past week is rated as never(0), 1-2 times per week(1.5), 3-4 times per week(3.5), every day(5), several times per day(10). On the severity scale, the severity of the experienced musculoskeletal discomfort is rated across the following anchors: 'Slightly uncomfortable'(1), 'Moderately uncomfortable (2), and 'Very uncomfortable'(3). On the work interference scale, the interference of the experienced musculoskeletal discomfort with the ability to work is rated across the following anchors: 'Not at all'(1), 'Slightly interfered'(2), and 'Substantially interfered'(3). High scores signify that discomfort frequency, severity, and working ability interference are high.
Measured: 4 weeks
Fatigue
Multidimensional Assessment of Fatigue (MAF): The scale contains 16 items and measures four dimensions of fatigue: severity (1-2), distress (3), degree of interference in activities of daily living (4-14), and timing (15-16). Scores range from 1 (no fatigue) to 50 (severe fatigue).
Measured: 4 weeks
Functional Status
The Functional Rating Index (FRI): FRI is a self-reporting instrument consisting of 10 items, each with 5 possible responses (0-4) that express graduating degrees of disability. Scoring ranges from 0-40, and the higher the score, the worse the functional status.
Measured: 4 weeks
Trunk Sagittal Plane Flexibility
Finger-to-floor test: Finger-to-floor distance test was used to measure lumbar mobility. This test measures the maximal possible spinal flexion range, and the participants bent their bodies forward without flexing their knees until there was a functional limitation. The distance between the tip of the right middle finger and the floor was measured as the finger-to-floor distance score (cm) using standard tape. Higher distances were indicative of greater hamstring tightness and limited lumbopelvic mobility.
Measured: 4 weeks
Trunk Frontal Plane Flexibility
Finger-to-floor test: Finger-to-floor distance test was used to measure lumbar mobility. This test measures the maximal possible spinal flexion range, and the participants laterally flexed their bodies forward without flexing their knees until there was a functional limitation. The distance between the tip of the third digit and the floor was measured (cm) using standard tape. Higher distances were indicative of greater frontal plane lumbopelvic mobility.
Measured: 4 weeks
Trunk Endurance
Static endurance of trunk muscles will be evaluated in plank position, supine hook lying position with the trunk flexed to 60 degrees, in the prone Biering-Sorenson Test position (prone with the upper body and abdomen off the edge of the table), and side bridge position. The ability to maintain these positions will be recorded in seconds with a chronometer. Higher time duration indicates higher muscular endurance.
Measured: 4 weeks
The Quality of Life
The Nottingham Health Profile (NHP): It is a 38-item questionnaire that assesses the domains of physical mobility, pain, sleep, social isolation, emotional reactions, and energy level. All questions have only yes/no answer options and each section score is weighted. Its wording is simple and easily understood, and can be completed by patients in 5 minutes. High scores indicate a decrease in quality of life. The highest score in any section is 100.
Measured: 4 weeks
Soliosis Specific Quality of Life
Scoliosis Research Society-22 Questionnaire (SRS-22): The questionnaire assesses five domains: function, pain, personal image, mental health (five questions each) and treatment satisfaction (two questions). Each question is scored between 1 (worst) and 5 (best). In the interrogation whose total score ranged from 22 to 111, the high score indicates that the quality of life for scoliosis is better.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start3 Apr 2022
- Primary completion1 Mar 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Yataş Yatak ve Yorgan San. Tic. A.Ş.
- Responsible party
- Principal investigator, Ayse Zengin Alpozgen, Istanbul University - Cerrahpasa
- Investigators
- Ipek Yeldan Karagoz, Prof., Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288972
- Sponsor's protocol ID
- gGqs42M4
- Status last verified
- Jun 2023
- First submitted
- 7 Mar 2022
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Mattress Types on Sleep Quality, Pain, Fatigue, Physical Adaptation, Functional Status, and Quality of Life in Adult Individuals With Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT05288972
- Acronym / sponsor ID
- gGqs42M4
- Conditions
- Idiopathic Scoliosis, Sleep
- Keywords
- spine, scoliosis, mattress, fatique, pain, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Yataş Yatak ve Yorgan San. Tic. A.Ş.
- Study start
- 3 Apr 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 21 Mar 2022 (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.
Objective: The aim of this study is to investigate the effect of different mattress materials on sleep behavior in adults with idiopathic scoliosis treated with non-invasive techniques.
Hypothesis 0: The use of a mattress that supports the spine properly, together with sleep accessories such as pillows, does not affect sleep behavior, does not alleviate back pain, and does not affect overall sleep quality and duration in adults with scoliosis.
Hypothesis 1: The use of a mattress that supports the spine properly, along with sleep accessories such as pillows, affects sleep behavior, helps relieve back pain, and affects overall sleep quality and duration in adults with scoliosis.
Possible outcomes: Improving sleep behavior and supporting the quality of life of individuals with idiopathic scoliosis.
Detailed description
Scoliosis, which is characterized by the curvature of the spine to the right or left, is a common orthopedic problem today. Due to the restriction of mobility and various symptoms of the disease, people may experience difficulties in their daily lives. The clinical manifestation of scoliosis in adults is most often characterized by the presence of back pain. Unbalanced, overloaded, and strained back muscles are under constant pressure and contribute greatly to back pain. The pain may be localized at the apex of the curve (apex) or around the concavity or may radiate down the leg. This can affect people's fatigue, physical adaptation, functional status, and quality of life. This study aims to examine sleep behavior and to investigate the effects of different mattress materials on pain, sleep quality, fatigue, physical adaptation, functional status, and quality of life in adults with idiopathic scoliosis treated with non-invasive techniques.
Voluntary participants who have been diagnosed with idiopathic scoliosis will be included in the study. Signed voluntary consent will be obtained from participants. The participants will be divided into 2 groups by block randomization according to the curve type and severity and will be evaluated as double-blind.
The first group will be given a mattress (M1) with the technical features suitable for scoliosis with supports the spine properly, and the control group will be given a mattress with standard technical features (M2). The mattresses will use for 4 weeks, at least 5 days a week, including at least 6 hours of sleep per day.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mattress 1 | Experimental | Device: Mattress 1Mattress 1 group will receive Polyurethane, Bonnel spring, medium-hard mattress |
| Mattress 2 | Active comparator | Device: Mattress 2Mattress 2 group will receive Polyurethane, pocket spring, medium mattress |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosed with idiopathic scoliosis
- Cobb angle between 10 and 50 degrees
- Age 18-45 years
- Last mattress use period > 6 months
Key exclusion criteria (9 listed)
- Surgical history (last 2 years)
- Lung problems, chronic respiratory or neuromuscular disease,
- Back Depression Scale score ≥ 17 \& taking antidepressants
- Insomnia Severity Index score ≥ 7 \& Using sleeping pills/hormones
- Diagnosed with a sleep disorder (history of restless sleep, sleep apnea…)
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 |
|---|---|---|
| Mattress 1A mattress (M1) with the technical features suitable for scoliosis with supports the spine properly. The mattress will use for 4 weeks, at least 5 days a week, including at least 6 hours of sleep per day. | Device | Mattress 1 |
| Mattress 2A mattress with standard technical features (M2). The mattress will use for 4 weeks, at least 5 days a week, including at least 6 hours of sleep per day. | Device | Mattress 2 |
Primary outcome
Self Reported Sleep Quality
Time frame: 4 weeks
Pittsburgh Sleep Quality Scale: It is a 19-item self-report scale that evaluates sleep quality and disturbance in the past month. Each item of the test is scored equally between 0-3. The scale consists of 7 subscales that assess subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disorders, use of sleep medication, and loss of daytime functionality. By summing up the subscales, a total score ranging from 0 to 21 is obtained. A total score greater than five, with 89.6% sensitivity and 86.5% specificity, indicates inadequate sleep quality and indicates severe impairment in at least two of the above-mentioned areas or moderate impairment in three areas.
Sleep Quality with Wearable Actigraph
Time frame: 1 week
Wearable Actigraph: The wearable actigraphs to be used in the study are small, lightweight, portable devices that can be worn in the form of a watch, measuring sleep and wake cycles, and sensitively detecting motor activities. In the study, wearable sleep actigraphs (Actigraph wgt3x-bt) will be used by attaching them to the non-dominant wrists of the participants, thus enabling the recording and storage of resting and activity patterns in a digital environment. Each participant will be asked to wear the wearable sleep actigraph in the form of a watch for 7 days (5 weekdays and 2 weekend days) during the last week of the study, and sleep data will be recorded. The recorded data will be transferred to the computer and after the transfer, the device will be reformatted and prepared for new recordings.
Sleep Quality with Non-Wearable Actigraph
Time frame: 4 weeks
Non-Wearable Actigraph: Non-wear actigraphs (Reston Z200) to be used in the study are made ready for use by laying them on the bed. While the cord of the device is laid inside the bed, the device is suspended from the side of the bed. Bed linen is placed on it. Thus, it does not disturb the person during sleep. Each participant will be asked to use the no-wear sleep actigraph laid on their bed every day (5 weekdays and 2 weekend days) throughout the study (4 weeks). With a free application installed on the smartphone, 30 days of sleep data will be recorded.
10 secondary outcomes
Subjective Feedback Inquiry
Time frame: 4 weeks
Pain intensity
Time frame: 4 weeks
Musculoskeletal Discomfort
Time frame: 4 weeks
Fatigue
Time frame: 4 weeks
Functional Status
Time frame: 4 weeks
Trunk Sagittal Plane Flexibility
Time frame: 4 weeks
Trunk Frontal Plane Flexibility
Time frame: 4 weeks
Trunk Endurance
Time frame: 4 weeks
The Quality of Life
Time frame: 4 weeks
Soliosis Specific Quality of Life
Time frame: 4 weeks
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 7 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Idiopathic Scoliosis
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Recruiting
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Scoliosis Idiopathic, Scoliosis; Adolescence
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
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.
Ipek Yeldan Karagoz, Prof. principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mattress 1 and Mattress 2 in people with Idiopathic Scoliosis and Sleep, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 4 inclusion and 9 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 7 Jun 2023. 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 Turkey (Türkiye). 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?
Self Reported Sleep Quality (time frame: 4 weeks). The study lists 3 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 7 Jun 2023.