The Effect of Different Mattress Types on Sleep Quality in Adult Individuals With Idiopathic Scoliosis

NCT05288972 | Completed

• 1 other identifier: gGqs42M4
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Idiopathic Scoliosis; Sleep

Keywords

spine; scoliosis; mattress; fatique; pain; quality of life

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  4 weeks

Secondary Outcomes (10)

• Subjective Feedback Inquiry

  4 weeks

• Pain intensity

  4 weeks

• Musculoskeletal Discomfort

  4 weeks

• Fatigue

  4 weeks

• Functional Status

  4 weeks

Study Arms (2)

Mattress 1

EXPERIMENTAL

Mattress 1 group will receive Polyurethane, Bonnel spring, medium-hard mattress

Device: Mattress 1

Mattress 2

ACTIVE COMPARATOR

Mattress 2 group will receive Polyurethane, pocket spring, medium mattress

Device: Mattress 2

Interventions

Mattress 1 DEVICE

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 1

Mattress 2 DEVICE

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.

Mattress 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with idiopathic scoliosis
• Cobb angle between 10 and 50 degrees
• Age 18-45 years
• Last mattress use period \> 6 months

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Yataş Yatak ve Yorgan San. Tic. A.Ş.: collaborator

Study Sites (1)

Istanbul University Cerrahpasa, Faculty of Health Science

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Scoliosis; Pain

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ipek Yeldan Karagoz, Prof.

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst.Prof.

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 21, 2022
• Study Start: April 3, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 15, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)