Lifestyle Modification Using an App in OSA

NCT03189940 | Completed DMC

• 1 other identifier: B-1504-296-302
• Study Type: interventional
• Target: 59
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aimed to investigate the effects of a mobile phone app linked to hospital electronic medical record (EMR) system on weight reduction and obstructive sleep apnea (OSA). Adults aged \> 20 years with witnessed snoring or sleep apnea from a sleep clinic of a tertiary center were prospectively enrolled, and the participats were randomized into app user and control groups. The mobile app was designed to collect daily lifestyle data by wearing a wrist activity tracker and reporting dietary intake. At the visit after 2 weeks of use, a summary of the lifestyle was displayed on the hospital EMR and reviewed by both physicians and app users. Further lifestyle modification was encouraged on the basis of the electronically collected data. In the control group, the lifestyle modification performed as the usual practice. All participants underwent Watch PAT and body mass index (BMI) measurement twice: on enrollment; and after 4-weeks follow up. Changes of BMI, and parameters of sleep related breathing were analyzed.

Conditions

Obstructive Sleep Apnea; Obesity

Outcome Measures

Primary Outcomes (1)

• changes in body weight

  body weight measurement and calculate into body mass index (BMI)

  base line and after 4weeks of life style modiciation

Secondary Outcomes (5)

• apnea hypopnea index (AHI)

  base line and after 4weeks of life style modiciation

• respiratory distress index (RDI)

  base line and after 4weeks of life style modiciation

• oxygen desaturation index (ODI)

  base line and after 4weeks of life style modiciation

• sleep time proportion with snoring loudness > 45dB

  base line and after 4weeks of life style modiciation

• lowest oxygen saturation

  base line and after 4weeks of life style modiciation

Study Arms (2)

App user group

ACTIVE COMPARATOR

Behavioral: Life style modification by using and app with a wrist-worn activity tracker

Control group

SHAM COMPARATOR

Control participants, the physicians could assess the lifestyle and recommend further lifestyle modification only on the basis of the participants' recalls

Behavioral: Conventional Life style modification

Interventions

Life style modification by using and app with a wrist-worn activity tracker BEHAVIORAL

The mobile app was designed to collect daily lifestyle data by wearing a wrist activity tracker and reporting dietary intake. At the visit after 2 weeks of use, a summary of the lifestyle was displayed on the hospital EMR and reviewed by both physicians and app users. Further lifestyle modification was encouraged on the basis of the electronically collected data.

App user group

Conventional Life style modification BEHAVIORAL

Physician's usual consultation for life style modification at 0 week, and 2 weeks of enrollment

Control group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ᆞ patients must agree to participate in our clinical study ᆞ patients without severe cardiopulmonary disease ᆞ patients must be with BMI \> 23 Kg/m2

You may not qualify if:

• ᆞ patients who did not agree ᆞ patients with severe cardiopulmonary disease ᆞpatients who are under treatment using a continuous positive airway pressure device or a mandibular advancement device ᆞ patients who were pregnant

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Jeong-Whun Kim, MD, PhD

  Seoul National University Bundang Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 16, 2017
• Study Start: June 20, 2016
• Primary Completion: July 26, 2016
• Study Completion: November 18, 2016
• Last Updated: June 16, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share