NCT06738940

Brief Summary

we hypothesize that long-term CPAP could results in increase weight and muscle composite by changing intake content and hormone and the effect was influenced by presence of CVD, social jet lag, and CPAP compliance. The project aims to conduct a telemedicine-based, multicenter, RCTs to compare the effect of 48-week CPAP and usual care on social jet lag, muscular fat, hormone, and attention and memory in 100 participants with moderate-severe OSA.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
14mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress54%
Jan 2025Jul 2027

First Submitted

Initial submission to the registry

November 13, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 18, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Expected
Last Updated

December 18, 2024

Status Verified

November 1, 2024

Enrollment Period

12 months

First QC Date

November 13, 2024

Last Update Submit

December 12, 2024

Conditions

Obstructive Sleep Apnea

Keywords

Body compositionContinuous positive airway pressureObstructive sleep apneasocial jet lagcognitionmuscular lipid

Outcome Measures

Primary Outcomes (2)

  • Changes in BMI

    By comparing the BMI of the CPAP group and the usual care group, observe the effect of CPAP on BMI.

    12 months

  • Changes in fat free mass

    By comparing the fat free mass of the CPAP group and the usual care group, observe the effect of CPAP on fat free mass. Fat free mass was measured via bioelectrical impedance analysis (X-SCAN PLUS II, Jawon Medical Co., Ltd., Korea).

    12 months

Secondary Outcomes (5)

  • The difference before and after the treatment of mid-sleep time

    12 months

  • The difference before and after the treatment of BMR (REE)

    12 months

  • The difference before and after the treatment of BMR (RQ)

    12 months

  • The difference before and after the treatment of Participants' nutrition intake

    12 months

  • The difference before and after the treatment of attention and memory task

    12 months

Other Outcomes (3)

  • Evaluate the difference between the usual care group and the CPAP group by comparing the activity levels measured by the Actiwatch and the sleeplog filled out by the patients.

    12 months

  • The difference before and after the treatment of Biochemistry, hormone and cytokine(blood test)

    12 months

  • The difference before and after the treatment of 24h blood pressure

    12 months

Study Arms (2)

Use of CPAP device

EXPERIMENTAL

CPAP 48 weeks

Device: CPAP

Usual care

NO INTERVENTION

Usual care 48 weeks

Interventions

CPAPDEVICE

Auto-CPAP treatment (AirSense™ 10 Autoset™, ResMed Inc., Australia) for 48 weeks

Use of CPAP device

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age:≧20 year-old
  • patients with moderate-severe OSA (AHI≥15/hr)

You may not qualify if:

  • skin allergy
  • wrist tattoos
  • BMI≧40 kg/m2
  • Neurological Disorders(Infection, Stroke, ALS, Myopathy, Brain tumor and Encephalitis)
  • Internal Diseases(cardiovascular disease or coronary artery disease was poorly controlled
  • chronic heart failure(including NYHA class 3 or more than NYHA class 3)
  • COPD(FEV1/FVC\<70)
  • Hyperthyroidism or Hypothyroidism
  • Primary Aldosteronism
  • Chronic Kidney Disease(eGFR\<30)
  • Acromegaly and Parkinson's disease)
  • Psychosis(Schizophrenia, bipolar disorder and depression)
  • Autoimmune disease(System Lupus Erythematosus, Rheumatoid arthritis, Sarcoidosis, Crohn's disease and Ulcerative Colitis)
  • Cancer(in last 5 years)
  • Have been diagnosed with obstructive sleep apnea
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Pei-Lin Lee, M.D., PhD

    Department of Internal Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei-Lin Lee, M.D., PhD

CONTACT

+886-223562755sleep.chronobiology.pl@gmail.com

Study Design

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

Study Record Dates

First Submitted

November 13, 2024

First Posted

December 18, 2024

Study Start

January 1, 2025

Primary Completion

December 31, 2025

Study Completion (Estimated)

July 31, 2027

Last Updated

December 18, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)