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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03730974
Other study ID # 7777BB
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 21, 2019
Est. completion date November 30, 2023

Study information

Verified date May 2022
Source University of Aarhus
Contact Sanne T Kristiansen, RN,MCN
Phone +45 60601777
Email stk@clin.au.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the study is to examine the efficacy of Protac Ball BlanketsTM (PBB) and specifically if the PBB will extend the total sleep time of patients with insomnia due to depression in two psychiatric outpatient clinics at Aarhus University Hospital and Odense University Hospital. Furthermore, it will be examined whether the PBB will reduce the sleep onset latency, number of awakenings, wake after sleep onset, need for sedatives and hypnotics, the self reported symptoms of depression and anxiety and improve the quality of sleep. 45 patients with depression and insomnia who receive outpatient treatment will be included in this study. The study is a randomized crossover trial. The data collection period lasts four weeks. Data will be collected using actigraphy, sleep diaries and questionnaires.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
Protac Ball BlanketTM (7kg Flexible)
All patients will wear a MotionLogger Micro Watch from Ambulatory Monitoring Inc. NY in all four weeks during all 24hours of the day.

Locations

Country Name City State
Denmark The Mood Disorders Clinic Aarhus Central Danish Region
Denmark Mental Health Department Odense - University Clinic Odense Region Of Southern Denmark

Sponsors (5)

Lead Sponsor Collaborator
University of Aarhus Aarhus University Hospital, Innovation Fund Denmark, Odense University Hospital, Protac A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in total night time sleep (TST) measured by actigraphy (Micro MotionLogger Watch) The investigators will detect the change in total night time sleep in minutes (actual sleep time, excluding sleep latency and wakes after sleep onset) by comparing the means of the difference in TST for each participant between period A and B or B and A Four weeks
Secondary Changes in sleep onset latency (SOL) The investigators will measure patients' SOL in minutes (time between registered bed time in sleep diaries and first sleep onset measured by actigraphy) and compare the means of the difference for each participant between periods Four weeks
Secondary Changes in number of awakenings measured by actigraphy (Micro MotionLogger Watch) The investigators will measure the number of awakenings between first sleep onset and the last wake up time registry and compare the means of the difference between period A and B or B and A for each participant Four weeks
Secondary Sedatives and hypnotics measured by medication registration use in sleep diaries The investigators will measure the change in use of per need sedatives and hypnotics in mg by comparing the means of the difference for each participant between periods Four weeks
Secondary Quality of sleep measured by questionnaire using the Pittsburgh Sleep Quality Index The investigators will measure and report the change in quality of sleep between periods. The total Pittsburgh Sleep Quality Index Score between 0-21, where "0" indicating no difficulty and "21" indicating severe difficulties is reported. Data will be collected at baseline, after two weeks and after four weeks. The difference between PSQI measured at week 2 and week 0 will be compared with the difference in PSQI measured at week 4 and week 2.
Secondary Symptoms of depression measured by the self-reported Hamilton Depression Rating Scale (HRSD6) The investigators will measure the change in self-reported symptoms of depression between periods. The total sum score between 0-50 is reported, where higher values represent worse outcome Data will be collected at baseline, after two weeks and after four weeks. The difference between the score measured at week 2 and week 0 will be compared with the difference in score measured at week 4 and week 2.
Secondary Insomnia Severity Status measured by questionnaire using the Insomnia Severity Index The investigators will measure the change in patients' insomnia severity status. The total score between 0-28 is reported, where higher values represent worse outcome Data will be collected at baseline, after two weeks and after four weeks. The difference between the score measured at week 2 and week 0 will be compared with the difference in score measured at week 4 and week 2.
Secondary Patients self-reported symptoms of depression measured by questionnaire using Major Depression Inventory (MDI) The investigators will measure the change in self-reported symptoms of depression between periods. The total score between 0-50 is reported, where higher values represent worse outcome. Data will be collected at baseline, after two weeks and after four weeks.The difference between the score measured at week 2 and week 0 will be compared with the difference in score measured at week 4 and week 2.
Secondary Symptoms of anxiety measured by questionnaire using Beck Anxiety Index (BAI) The investigators will measure the change in self-reported symptoms of anxiety between periods. The total score between 0-63 is reported, where higher values represent worse outcome. Data will be collected at baseline, after two weeks and after four weeks.The difference between the score measured at week 2 and week 0 will be compared with the difference in score measured at week 4 and week 2.
Secondary Patient-reported outcomes concerning interpersonal sensitivity, neurasthenia, anxiety, and depression measured by questionnaire using The Self-Reported Symptom State Scale SCL-28 The investigators will measure the change in self-reported symptoms between periods. Sub scales are combined to compute a total score. The range for each sub scale are: Interpersonal Sensitivity 0-32, Neurasthenia 0-28, Anxiety 0-32 and Depression 0-24. Both total score and sub scale scores will be reported. The total score range between 0-112, where higher value represent worse outcome. Because of an overlap in one question between the sub scales anxiety and depression question number 31 is only considered in the total sum ones. Data will be collected at baseline, after two weeks and after four weeks.The difference between the score measured at week 2 and week 0 will be compared with the difference in score measured at week 4 and week 2.
Secondary Changes in wake after sleep onset (WASO) measured by actigraphy The investigators will measure patients total time awake between initial sleep onset and the final morning awakening in minutes and compare the means of the difference between period A and B or B and A for each participant Four weeks
See also
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Completed NCT03000894 - CBT-I as Early Intervention of Mood Disorders N/A
Completed NCT04598425 - Cognitive Behavioral Therapy for Insomnia (CBTi) in Patients With Mental Illness N/A