NCT01483716

Brief Summary

Obesity is an escalating problem in the UK and a proportion of these patients have a condition known as Obesity Hypoventilation Syndrome (OHS). This syndrome is associated with symptoms of breathlessness, reduction in exercise capacity, fatigue and headaches. Previous research has shown that patients with this condition tend to use healthcare services more frequently and are often at risk of other diseases such as diabetes mellitus and high blood pressure. Currently, the mainstay of treatment is noninvasive ventilation (NIV), this is a mask ventilator that patients use overnight to improve oxygen levels and remove carbon dioxide (the waste gas of breathing), however this does not fully treat the underlying problem. The research group has shown that NIV helps improve activity and contributes to weight loss in this group of patients. The aim of this research will be to investigate the effect of an exercise and nutrition programme in addition to NIV on weight loss and activity levels compared to NIV alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2011

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 18, 2015

Status Verified

August 1, 2015

Enrollment Period

3.1 years

First QC Date

November 30, 2011

Last Update Submit

August 16, 2015

Conditions

Obesity Hypoventilation Syndrome

Outcome Measures

Primary Outcomes (1)

  • % Weight loss

    12 months

Secondary Outcomes (1)

  • 6 minute walk test

    12 months

Study Arms (2)

Control

NO INTERVENTION

NIV alone

Intervention

EXPERIMENTAL

Rehabilitation arm

Behavioral: Rehabilitation

Interventions

RehabilitationBEHAVIORAL
Intervention

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of OHS
  • Age \>18
  • BMI \> 30 kg/m2
  • Chronic hypercapnia , daytime PaCO2 \>6kPa
  • FEV1/FVC ≥70%
  • Evidence of sleep disordered breathing on overnight studies
  • Tolerated NIV \> 4hrs on 1st night during initiation of NIV

You may not qualify if:

  • Hypercapnic respiratory failure secondary to an identifiable cause other than OHS.
  • Age \<18
  • Respiratory acidosis (pH \<7.35)
  • Wheelchair/bedbound patients
  • Cognitive impairment which would prevent the subject from complying with trial protocol
  • Unstable coronary artery syndrome
  • Patients postintubation or decannulation following treatment requiring acute hypercapnic respiratory failure
  • Patients undergoing renal replacement therapy
  • Critical peripheral vascular disease
  • Disabling locomotor disability preventing participation in exercises involved in the rehabilitation programme
  • Pregnancy
  • Bariatric surgery planned within 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's and St Thomas' NHS Trust

London, SE1 7EH, United Kingdom

Location

Related Publications (1)

  • Mandal S, Suh ES, Harding R, Vaughan-France A, Ramsay M, Connolly B, Bear DE, MacLaughlin H, Greenwood SA, Polkey MI, Elliott M, Chen T, Douiri A, Moxham J, Murphy PB, Hart N. Nutrition and Exercise Rehabilitation in Obesity hypoventilation syndrome (NERO): a pilot randomised controlled trial. Thorax. 2018 Jan;73(1):62-69. doi: 10.1136/thoraxjnl-2016-209826. Epub 2017 Sep 29.

    PMID: 28971973DERIVED

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Sleep Apnea, ObstructiveSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesHypoventilationRespiratory InsufficiencySleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Nicholas Hart

    Guy's and St Thomas' NHS Foundation Trust

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Fellow

Study Record Dates

First Submitted

November 30, 2011

First Posted

December 1, 2011

Study Start

November 1, 2011

Primary Completion

December 1, 2014

Study Completion

August 1, 2015

Last Updated

August 18, 2015

Record last verified: 2015-08

Locations

GB(1)