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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT05288972
Study groupRoleWhat they receive
Mattress 1ExperimentalMattress 1 group will receive Polyurethane, Bonnel spring, medium-hard mattress
Receives: Device: Mattress 1
Mattress 2Active comparatorMattress 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.

  1. 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

  2. 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

  3. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

  1. First posted21 Mar 2022
  2. Study start3 Apr 2022
  3. Primary completion1 Mar 2023
  4. Study completion15 Mar 2023

Resources

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)
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

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.

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