High-Altitude Neurodegeneration Cohort (HANC) Study
- Sponsor
- West China Hospital
- Study ID
- NCT07657520
- Status
- Recruiting
Conditions
- Multiple System Atrophy
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - 75 Years
- Healthy Volunteers
- Accepted
Interventions
- No Intervention: Observational Cohort — OTHERNo intervention; observation of altitude exposure and SpO₂ levels
Study Details
Chronic physiological hypoxia has been implicated in the pathogenesis of multiple system atrophy (MSA), a fatal neurodegenerative disorder of unknown etiology. This prospective, multicenter, observational cohort study (Phase II of the High-Altitude Neurodegeneration Cohort \[HANC\] study) aims to validate the association between chronic hypoxia exposure and incident MSA risk. A total of 20,000 Han Chinese participants aged 40-75 years will be enrolled from 23 sites across China spanning an altitude gradient from 4 m to 4,500 m. All participants will undergo standardized in-person assessment including questionnaires, physical examination, blood collection, and 3-night consecutive nocturnal pulse oximetry monitoring. Participants are to be followed for incident MSA over 12 months. The primary outcome is newly diagnosed MSA (probable or definite per Gilman consensus criteria), adjudicated by an independent panel of movement disorders specialists. Secondary outcomes include the association between altitude strata and MSA incidence, the association between mean nocturnal SpO₂ and MSA incidence, and incidence rates across MSA subtypes (MSA-P and MSA-C).
Key Dates
- First listed
- Jun 18, 2026
- Start date
- Jun 13, 2026
- Status verified
- Jun 2026
- Primary completion
- Jul 30, 2027
- Completion
- Jul 30, 2027
Study Design
- Enrollment
- 20,000 participants (estimated)
Arms
- Arm: GROUP_1_Lowland (<500 m)Participants residing at altitudes below 500 meters. Enrollment sites include Shanghai (4 m), Guangzhou, Suzhou, Hangzhou, Wuhan, Changsha, Nanjing, and Zhengzhou.
- Arm: GROUP_2_Intermediate (500-2,000 m)Participants residing at altitudes between 500 and 2,000 meters. Enrollment sites include Kunming (1,890 m), Guiyang (1,100 m), Lanzhou (1,520 m), Yinchuan (1,100 m), Xi'an (400 m - borderline, verify), Chengdu (500 m), and Chongqing (240 m).
- Arm: GROUP_3_Highland (2,000-3,500 m)Participants residing at altitudes between 2,000 and 3,500 meters. Enrollment sites include Xining (2,295 m), Golog (3,700 m - verify), Haixi (2,980 m), Yushu (3,700 m), and Ganzi (3,400 m).
- Arm: GROUP_4_Extreme Altitude (>3,500 m)Participants residing at altitudes above 3,500 meters. Enrollment sites include Lhasa (3,656 m), Nagqu (4,500 m), and Ali (4,500 m).
Primary Outcome Measure
Incidence of Multiple System Atrophy (MSA) at 12 Months [ Time Frame: Baseline to Month 12 ]
Central Contacts
- Zhigang Lan, M.D. PhD.18980606446
Related Studies
- Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at SanfordRecruiting · Sanford Health · Sioux Falls, South Dakota
- Natural History Study of SynucleinopathiesRecruiting · NYU Langone Health · Boston, Massachusetts
- Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic FailurePHASE1 · Recruiting · Vanderbilt University Medical Center · Nashville, Tennessee
- Overnight Trials With Heat Stress in Autonomic Failure Patients With Supine HypertensionRecruiting · Vanderbilt University Medical Center · Nashville, Tennessee