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Ball Blankets on Insomnia in Depression in Outpatient Clinics

NCT03730974 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-05-23

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Innovation Fund Denmark

    collaborator INDIV

  • Protac A/S

    collaborator UNKNOWN

  • Aarhus University Hospital

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Erik R Larsen, MD PhD · Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-21
Primary Completion
2023-06-01
Completion
2023-11-30

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03730974 on ClinicalTrials.gov