Ball Blankets on Insomnia in Depression in Outpatient Clinics

NCT03730974 | Unknown

• 1 other identifier: 7777BB
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Insomnia Due to Mental Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Changes in sleep onset latency (SOL)

  Four weeks

• Changes in number of awakenings measured by actigraphy (Micro MotionLogger Watch)

  Four weeks

• Sedatives and hypnotics measured by medication registration use in sleep diaries

  Four weeks

• Quality of sleep measured by questionnaire using the Pittsburgh Sleep Quality Index

  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.

• Symptoms of depression measured by the self-reported Hamilton Depression Rating Scale (HRSD6)

  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.

Study Arms (2)

Experimental arm AB (Ball blanket + TAU)

EXPERIMENTAL

Participants will be randomized into either sequence AB or BA each lasting four weeks. Patients that are randomized to the AB sequence receive intervention A (Protac Ball BlanketTM 7 kg Flexible) in the first two weeks and treatment B treatment as usual (TAU) in the second period.

Device: Protac Ball BlanketTM (7kg Flexible)

Experimental arm BA (TAU + Ball blanket)

EXPERIMENTAL

Patients that are randomized to the BA sequence receive treatment B (TAU) in the first period and intervention A in the second period (Protac Ball BlanketTM 7kg Flexible).

Device: Protac Ball BlanketTM (7kg Flexible)

Interventions

Protac Ball BlanketTM (7kg Flexible) DEVICE

All patients will wear a MotionLogger Micro Watch from Ambulatory Monitoring Inc. NY in all four weeks during all 24hours of the day.

Also known as: MotionLogger Micro Watch from Ambulatory Monitoring Inc. NY

Experimental arm AB (Ball blanket + TAU); Experimental arm BA (TAU + Ball blanket)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants: Patients with depression according to ICD-10 (F32-33) or (F32-33 in combination with F40-41.2) (males and females, aged ≥18 years) who receive outpatient treatment in The Mood Disorders Clinic, Aarhus University Hospital, Risskov, Denmark and in The Clinic of Affective Disorders, Department of Psychiatry, Psychiatry in The Region of Southern Denmark.
• Participants must either experience poor sleep quality, sleep onset latency or wake time after sleep onset of: (a) ≥31 min; (b) occurring ≥3 nights a week; (c) for ≥ 14 days (31) or early wake ups, and have a Global Pittsburgh Sleep Quality Index Score ≥5.

You may not qualify if:

• Patients that, according to ICD-10 criteria, have been depressed \>2 years
• Patients suffering from hypersomnia (ICD-10: F51.13)
• Patients with current alcohol- or drug abuse (ICD-10: F10-19)
• Patients with diseases directly influencing sleep quality (such as severe chronic pain issues, sleep apnoea o.a.)
• Patients receiving medications causing sleep loss and disturbed sleep
• Patients with Circadian Rhythm Sleep-Wake Disorders (ICD-10; G47.20-47.26)

Sponsors & Collaborators

• University of Aarhus: lead
• Innovation Fund Denmark: collaborator
• Protac A/S: collaborator
• Aarhus University Hospital: collaborator
• Odense University Hospital: collaborator

Study Sites (2)

The Mood Disorders Clinic

Aarhus, Central Danish Region, 8200, Denmark

RECRUITING

Mental Health Department Odense - University Clinic

Odense, Region Syddanmark, 5000, Denmark

RECRUITING

Related Publications (1)

• Kristiansen ST, Videbech P, Bjerrum MB, Larsen ER. The efficacy of ball blankets on insomnia in depression in outpatient clinics: study protocol for a randomized crossover multicentre trial. Trials. 2020 Aug 17;21(1):720. doi: 10.1186/s13063-020-04638-y.

  PMID: 32807208 DERIVED

Study Officials

• Erik R Larsen, MD PhD

  Odense University Hospital

  STUDY DIRECTOR

Central Study Contacts

Sanne T Kristiansen, RN,MCN

CONTACT

+45 60601777; stk@clin.au.dk

Erik R Larsen, MD PhD

CONTACT

+45 51880595; Erik.Roj.Larsen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study has a randomized 2-sequence, 2-period, 2-treatment crossover design.

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: November 5, 2018
• Study Start: November 21, 2019
• Primary Completion: June 1, 2023
• Study Completion: November 30, 2023
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)