NCT02114424

Brief Summary

POSAS can be treated with CPAP however there is now evidence from a few studies that Night Balance is effective in POSAS. Night Balance seems to be better accepted than CPAP so we would like to examine if we could find similar results in routine clinical work and especially we would like to confirm the subjective effects with objective measures i.e. a reduction in AHI in the supine position during sleep.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
16 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

April 15, 2014

Status Verified

April 1, 2014

Enrollment Period

1.1 years

First QC Date

April 10, 2014

Last Update Submit

April 13, 2014

Conditions

Obstructive Sleep Apnea (OSAS)

Keywords

Positional Obstructive sleep apnea syndrome (POSAS)Obstructive sleep apnea syndrome (OSAS)Apnea-Hypnea Index (AHI)Sleep questionnairePositional sleep apnea beltAdverse eventsCompliance

Outcome Measures

Primary Outcomes (1)

  • Efficacy and adherence of Night Balance in POSAS versus no therapy after 2 months (Sleep supine and AHI).

    AFter 2 months assessment will be done by sleep questionnaires and CRM

    After 2 months

Secondary Outcomes (1)

  • Efficacy and adherence of Night Balance in POSAS versus no therapy after 2 months (Sleep supine).

    6 months after entry

Study Arms (2)

Positional vibrator belt

ACTIVE COMPARATOR

Positional belt to avoid supine sleep.

Device: Positional vibrator belt

No Night balance

NO INTERVENTION

the first 2 months without Night Balance

Interventions

Positional vibrator beltDEVICE

Belt with vibarator to avoid sleep supine

Also known as: Night Balance, B.V,, 2629 JD Delft, The Netherlands
Positional vibrator belt

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • AHI supine ≥ AHI non-supine x 2,
  • AHI supine ≥ 10
  • AHI non-supine \<10
  • % sleep time in supine position
  • Daytime tiredness and/or disturbed sleep and/or snoring

You may not qualify if:

  • Not able or willing to cooperate
  • Age \<18 years
  • Central Sleep Apnea
  • Night or shifting work
  • Severe chronic heart failure or severe COPD
  • A medical history of known causes of tiredness by day or severe sleep disruption (insomnia, PLMS, Narcolepsy)
  • Seizure disorder
  • A known medical history of mental retardation, memory disorders or psychiatric disorders
  • The inability to provide informed consent
  • Pacemaker
  • Pain in joints or shoulder
  • Other reasons unable to sleep in lateral positions.
  • Pregnant females or females that plan pregnancy in study period (problems sleeping supine)
  • Breastfeeding females in study period (other reasons for disturbed sleep)
  • Plan weight reduction in study period
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glostrup University Hospital

Glostrup Municipality, 2600, Denmark

Location

Related Publications (1)

  • 23. van der Star A, Mekking S, van Riet M. The technical validation of the Sleep Position Trainer. Nightbalance Research and Development [Internet]. 2012 Oct [cited 2013 Dec 6]:1-12. Available from http://www.nightbalance.com/research.

    BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, ObstructivePatient Compliance

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Philip Toennesen, M.D., Ph.D.

    GlsotrupUH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip Toennesen, M.D., Ph.D.

CONTACT

(45)51264850philip.toennesen.01@regionh.dk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior consultant, Dept. of Sleep, Dept. of Clin. neurophysiology

Study Record Dates

First Submitted

April 10, 2014

First Posted

April 15, 2014

Study Start

May 1, 2014

Primary Completion

June 1, 2015

Study Completion

February 1, 2016

Last Updated

April 15, 2014

Record last verified: 2014-04

Locations

DK(1)