NCT03163615

Brief Summary

The purpose of this study is to evaluate the effect of Tibet Rhodiola Capsule on hypoxia and the cardiovascular risk factors in patients with mild to moderate OSA.

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

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

May 15, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

June 17, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
Last Updated

July 26, 2017

Status Verified

July 1, 2017

Enrollment Period

9 months

First QC Date

May 15, 2017

Last Update Submit

July 25, 2017

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Average oxygen saturation

    Average oxygen saturation was assessed by home sleep apnea testing(HSAT)

    Change from Baseline to 84±4days

Secondary Outcomes (10)

  • Lowest saturation

    baseline and 84±4days

  • Percentage of total sleep time associated with saturation lower than 90% (T90SaO2 )

    baseline and 84±4days

  • AHI

    baseline and 84±4days

  • Heart rate variability

    baseline and 84±4days

  • Coronary flow reserve

    baseline and 84±4days

  • +5 more secondary outcomes

Study Arms (2)

Tibet Rhodiola Capsule

EXPERIMENTAL
Drug: Tibet Rhodiola Capsule

Placebo oral capsule

PLACEBO COMPARATOR
Drug: Placebo oral capsule

Interventions

Tibet Rhodiola CapsuleDRUG

4 capsules, po, from admission up to 84 days

Also known as: Xueyu Hongjingtian Huoli Jiaonang
Tibet Rhodiola Capsule
Placebo oral capsuleDRUG

4 capsules, po, from admission up to 84 days

Placebo oral capsule

Eligibility Criteria

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

You may qualify if:

  • Age \>18 years, males or females;
  • HSAT or PSG testing within recent 3 months;
  • AHI 5-30 and lowest oxygen saturation\<85%;
  • Refuse to accept CPAP, Mandibular orthosis device, surgery, or other medications to improve OSA;
  • Written informed consent.

You may not qualify if:

  • History of CPAP, Mandibular orthosis device, surgery, or other medications to improve OSA;
  • Significant central sleep apnea;
  • Histories of other sleep disorders: insomnia, chronic sleep deprivation, long-term use of sleeping pills or sedatives, restless legs syndrome;
  • Histories of underlying heart disease (cardiomyopathy, myocarditis, pericarditis or severe valvular disease), cardiogenic shock and heart failure (NYHA or Killip class 3-4), persistent atrial or ventricular arrhythmias;
  • History of myocardial infarction, coronary revascularization, and a known degree of stenosis \> 75% of the coronary lesions;
  • Histories of known serious liver dysfunction (ALT or AST levels above 3 times the normal limit), renal insufficiency (GFR\<30ml/min), moderate and severe chronic obstructive pulmonary disease, and pulmonary arterial hypertension;
  • Patients with malignant tumors, lymphoma and neuropsychiatric disorders;
  • Patients with major surgery or trauma within 3 months, and active bleeding or cerebrovascular accident within 6 months;
  • History of anemia (hemoglobin\<90g/L) or thrombocytopenia (thrombocyte \<90×10\^9/L);
  • Breastfeeding, pregnant, or potentially fertile women;
  • Patients who have known to be allergic to Tibet Rhodiola Capsule or its components or patients with serious adverse effect;
  • Participation in other clinical trials in recent 3 months;
  • Patients who cannot complete this trial or comply with the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, 100029, China

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 23, 2017

Study Start

June 17, 2017

Primary Completion

February 28, 2018

Study Completion

May 30, 2018

Last Updated

July 26, 2017

Record last verified: 2017-07

Locations

CN(1)